30 Pharmaceutical Compliance jobs in Egypt
Compliance Officer
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***Key Responsibilities**
As a** Compliance Officer**, you will be responsible for providing management and day to day support to the Company’s overall Compliance activities across all business units and functions ensuring that risks and controls from project inception to support within their business unit are identified, prioritized, effectively managed, and monitored. Additionally this role should work within the business unit to ensure Company follows the required internal and external compliance standards and delivers a reduction in the overall risk profile.
The primary responsibility of this position will be:
- Compliance (including Operations, Regulatory and Policy Framework)
- Corporate Governance Compliance
- Support Risk Management
- Management Monitoring
- Compliance Policy/SOPs Formation, lunch and monitoring
- Compliance Maintenance to Pharmaceutical Laws across the countries where the Company operates.
**Compliance **(including Operations, Regulatory and Policy Framework)**:
- Contribute to maintenance of the Business Unit delivery and operational frameworks (Activities, deliverables, roles, and responsibilities) and ensure alignment to country regulations.
- Ensure Company activities align with SFDA (and equivalent outside Saudi) Regulatory requirements and liaise with commercial/marketing to ensure proper implementation of the regulations.
- Contribute to ensuring the Company is keeping up to date with regulatory and legal requirements through a pro-active knowledge management program in alignment with legal function.
- Ensure the Company and all its BU and functions adhere to its Bylaws, charters. Policies and authority levels.
- Support tracking and managing all CAPAs across BU, department and functions and escalate to top management and audit committee any significant gaps and findings.
**Corporate Governance Compliance**
- Ensure that the Company complies and adheres to all required regulatory filling and keeps up-to-date corporate registry and official documents.
- Ensuring that policies and SOPs are in place to ensure proper management and tracking of regulatory filling and disclosures including capital market authority requirements.
**Risk Management**
- Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting the Company
- Facilitate risk identification and risk discussions within BU, both operational risk, regulatory and strategic risk
- Assist the Management to make risk informed decisions through a comprehensive Risk Dashboard
- Raise and approve (where necessary) Policy Exceptions and significant Risks
- Input into, review and enforce compliance within Policies and Standards as required within Business Unit
- Ensure emerging risks are identified and escalated appropriately and in a timely manner
- Perform GRC requirements within third party framework
- Ensure awareness of process and report suspected breach
- Provide training and education program to ensure ongoing awareness on new and updated Policies and Standards within the Company
**Audit Support**
- Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies
- Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business
- Report status on CAPA’s to Business Unit RMCB
**Policy Formation**
- Create, review, and approve policy, standards, procedures, guidance, and training for compliance with relevant legislation and SOP Requirements.
- Support reviews of the commercial and marketing activities to make sure it complies with legislation and specifies any required changes within their Business Unit
**Basic Qualifications**
- Bachelor’s Degree in Pharmaceutical, Accounting.
- Have 7:10 years’ experience in Compliance and Risk Management.
- Experience in Pharmaceutical industry.
- Certifications in IFSA, CCA.
- Fluent in English and Arabic.
QA Compliance Section Head - Pharmaceutical
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**MultiCare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. MultiCare has +21 years of prominent existence in the local market and has almost +69 products marketed and more to come through the pipelines. **MultiCare** Egypt for Pharmaceutical Industries is the manufacturing facility which located at the Industrial Zone - New Cairo and its HQ is close by the facility as well in New Cairo. We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.
Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).
**Vacancy**:
We are recruiting an expert professional to join the QA Team as Quality Compliance Section Head as per the following details:
- **Location **:New Cairo
- **Reporting**:QA Manager
- **Grade**:qAc01/qAc03
**Job Purpose**:
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.
**A.Essential Duties and Responsibilities**:
- Ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels
- Complete minor and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation. Make recommendations to department management regarding results of investigation and process improvements, when necessary. Make final recommended batch disposition. Manage the CAPA system to ensure that corrective and preventative actions are made and followed
- Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to Management Team, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented
- Provide support to functional areas regarding the Change Control System by providing assessments, work closure, and follow-up. Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to so that an informed decision can be made
- Promote a highly safety conscious culture and EHS focused workforce
- Represent QA on key forums and teams to evaluate and provide QA recommendations on products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements for any proposed changes or new information
- Perform all job responsibilities in compliance with applicable regulations, current operating procedures and industry practice
- Participate in investigations of escalations, lead the investigation report preparations and follow up all necessary actions
- Prepare annual site Self-Inspection plan and ensure activities are completed on-time
- Maintain document control system (issuing, reviewing, updating and canceling) for all company processes including Standard Operating Procedures (SOPs) and Master Production Batch Records
- Identify key manufacturing risks across different functions and devise mechanisms to mitigate them
- Drive investigations of Critical Deviations & Complaints as a member of Quality Compliance team and provide guidance on related topics
**B. Job Requirements**:
- Bachelor’s degree in science or related discipline (e.g. Chemistry, Pharmacy, etc)
- Professional knowledge and experience of GMP and Total Quality Management System
- Strong verbal and written communication skills
- Strong analytical and problem-solving skills
- Proficient to advanced Microsoft Excel skills; Microsoft Access skills a plus
- **At least 8-10 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, in which at least 3 year in Quality Compliance Managerial
Compliance Officer / Money Laundry Specialist
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**Key responsibilities**:
- Minimum 5 years of work experience
**Relevant skills, knowledge, and experience**
- Minimum 5 years of experience.
Quality Assurance
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Analyzing users stories and/use cases/requirements for validity and feasibility
Collaborate closely with other team members and departments
- Execute all levels of testing (System, Integration, and Regression)
- Design and develop automation scripts when needed
- Detect and track software defects and inconsistencies
- Provide timely solutions
- Provide support and documentation
Your Role Requirements: A bachelor's degree in computer science or related field.
- Up-to-date knowledge of software test design and testing methodologies.
- Working knowledge of manual test techniques and compatibility with various software programs.
- Basic Automatic experience.
- Working knowledge of programming.
- Excellent communication and critical thinking skills.
- Good organizational skills and detail-oriented mindset.
- Good time-management skills.
- Great interpersonal and communication skills.
**Job Type**: Contract
Pay: E£17,171.42 per month
Quality Assurance Head
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- Comprise special GxP requirements.
- Ensure that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective & preventive actions (CAPA) and/or escalation of issues
- Ensure implementation of applicable Quality Standards and governance processes and all regulatory controls are in place in relevant process steps
- Ensure adherence to GxP, any further legal and company internal regulations for manufacturing, control and distribution operations and to HSE guidelines and requirements
- Ensure implementation of defined Key Quality Indicators in the area of responsibility to monitor on an on-going basis that relevant processes are in control and compliant. -Ensure regularly review and assessment of KQIs at the Leadership Team level.
- Ensure adequate escalation of issues and support their timely resolution & provide quality oversight for deviations and adequate corrective and preventive actions (CAPA’s) are implemented.
- Provide quality oversight for planned changes.
- Adequate regulatory inspection preparation, management and follow-up in the area of responsibility.
- Communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time.
- Implementation of adequate training within the area of responsibility for all GXP activities by defining, planning and supporting training activities.
- Ensure that processes are in place to communicate country specific requirements to the Region and headquarter organizations for all GXP areas and assess their implications for the compliance of existing processes and systems.
- Initiate remediation activities, as necessary, to ensure ongoing compliance.
- Adequate processing of complaints.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- University degree
- Extensive experience in Operation Management and Execution with people management experience
- Sustained Performance & Behavior
- Good understanding of country, regional and local dynamics
- Demonstrated ability to think broadly and innovate within the Pharmaceutical business
- Working knowledge of Pharmaceutical procedures and trends
**Division**
- SANDOZ
**Business Unit**
- Commercial OPS SIR SZ
**Country**
- Egypt
**Work Location**
- Cairo
**Company/Legal Entity**
- HEXAL EGY
**Functional Area**
- Quality
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
Quality Assurance Engineer
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At Electrolux, a leading global appliance company, we strive every day to shape living for the better for our consumers, our people and our planet. We share ideas and collaborate so that together, we can develop solutions that deliver enjoyable and sustainable living.
Come join us as you are. We believe diverse perspectives make us stronger and more innovative. In our global community of people from 100+ countries, we listen to each other, actively contribute, and grow together.
Join us in our exciting quest to build the future home.
What you'll do:
The position is responsible for ensuring that a company's products and processes meet established quality standards by identifying shortfalls, developing corrective measures, and implementing quality control systems.
**In detail, you will**:
- Responsible for process and system quality audits against all standards.
- Ensure adherence to the Quality management system.
- Analyze Quality data coming from customer feedback, product control and capability analysis.
- Create and follow-up actions related to continuous improvement in relation of the KPIs results and analysis.
- Work closely with the manufacturing team to create and update FMEA.
- Establishing the required action plans to improve final product & customer returns KPIs
- Implement the requirement of quality management system ISO 9001-2015.
- Generate & create ideas and techniques for continuous improvement related to this area of interest to minimize the cost of processing or inspection.
Qualifications:
- Bachelor’s degree engineering, (Mechanical/Mechatronics are preferred)
- Experience: 0-3 years of experience in quality and preferred with industrial quality.
- Fluent Spoken and written command of English language.
- Strong Logical and analytical thinking.
- Problem solving skills through innovation and creativity
Where you'll be:
You will be based at Electrolux Manufacturing Site at 10th of Ramadan City
- Sharkia Governate
- Egypt.
As part of Electrolux, we will continuously invest in you and your development. There are no barriers to where your career could take you.
Find out more on:
Electrolux Group
(#LI-SS3)
Quality Assurance Executive
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- Responsible for calibrating, monitoring, and supporting the quality standards between internal and external parties.
- Create process documentation/workflows/Work instructions, knowledge articles, and self-service guidance.
- Collect and document business requirements for project and process improvement/automation efforts.
- Perform an internal audit to make sure that all departments are working by the officially agreed process.
- Facilitate process workflow modeling to collaborate on process improvements, automation capabilities, and clearly defined end-to-end use cases.
- Review information and trends to ensure that the output of processes achieves the desired results and that services meet agreed service levels.
- Conduct maturity assessments against the process activities to highlight areas of improvement or concerns.
- Identify issues and risks.
- Bring inconsistencies and problems to the attention of management.
- Participate in solving problems.
- Track major incidents and ensure adherence to the process and escalation of requirements within the various support and delivery areas.
- Extract reports and provide a high-level analysis of data for review.
- Participate in the planning of QA department objectives.
- Manage and improve the quality control process.
- Set goals and metrics, and report on quality control results continuously.
- Communicate quality concerns with stakeholders.
- Developing test plans and test cases to ensure that our services meet quality standards.
- Working with cross-functional teams to ensure that quality is built into the product development process.
- Investigating and resolving any quality-related issues that arise.
- Continuously improving the QA process to ensure that it is effective and efficient.
**Skills/Qualifications**:
- Previous working experience in the localization industry minimum of 2 years is preferable.
- Previous working experience as a Quality Specialist minimum of 2 years.
- Working knowledge of tools, methods, and concepts of quality assurance.
- Bachelors in business administration, computer science, or a similar relevant field.
- Excellent organizational and time management skills.
- Outstanding communication and presentation skills.
- Critical thinker & self-motivated.
- Creative problem solver.
- Great analytical skills.
- Data-driven approach.
- Excellent in MS Office, Adobe Acrobat, and PowerPoint (many reports and presentations will be required)
- Fluent in English.
- Strong Leadership and Communication skills.
- Knowledge of ISO 9001:2015 & ISO 17100:2015 is preferable.
- Background localization & translation industry is preferable.
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Software Pqe (Quality Assurance)
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- In the context of complex automotive projects with multiple teams working in parallel, manage the quality of the intermediate and final deliveries (inter-team deliveries and customer deliveries).
- Execute both random inspections and planned audits on different work products in the project.
- Identify and evaluate quality metrics and present them to management and customers.
- Proactively support project managers to plan corrective actions to improve quality.
- Execute different quality audits on selected projects inside the organization.
**REQUIREMENTS**:
- Bachelor’s degree in Electronic Engineering /Computer Engineering /Computer Science or equivalent combination of education/experience.
- 3+ years of hands-on experience in the Software Quality Assurance / Software Development field.
- Strong knowledge of Agile, CMMI, ASPICE 3.1, and ISO26262.
- Experience with the Software development process, Systems engineering methodologies, and test techniques.
- Ability to troubleshoot issues to resolution. Strong problem solving and root cause analysis skills.
- Capability to enforce discipline and process compliance within complex project environments.
- Excellent communication and negotiation skills with other teams and the customer.
- Very good English language (spoken and written) is required.
**Job Features**:
- Job Category- Embedded
Senior Quality Assurance Specialist
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- **Objectives of this Role**:
- Interpret, build upon, and comply with company quality assurance standards.
- Carefully maintain a complaint and nonconformance processing through records. and tracking systems, including root causes and corrective actions.
- Document quality assurance activities with internal reporting and audits.
- Develop new standards for service with improvements as needed and create testing protocols for implementation across all service lines.
- Identify training needs and take action to ensure company-wide compliance.
- **Daily and Monthly Responsibilities**:
- Providing high-quality car and driver services meeting customer needs in car rental services and providing them with quality services.
- Preparing and implementing quality assurance policies and procedures.
- Performing routine inspections and quality tests.
- Plan, execute, and oversee inspection and testing of services to confirm quality conformance to specifications and deliverables.
- Assist operations in tracking, documenting, and reporting quality issues.
- Analyze and investigate customers' complaints or reported quality issues to ensure closure following company policies and procedures.
- Documenting quality assurance activities and creating audit reports.
- Seek customer satisfaction, taking into account their requirements.
- Making recommendations for improvement.
- Increase customer satisfaction by managing Google Customer Reviews and company ratings on RentalCars.
- Identification of measures for a sustainable increase in customer satisfaction and service quality and to reduce customer complaints.
- Develop or update company inspection procedures to ensure capture and investigation, as well as proper documentation of complaints.
- Analyzing problem logs to identify and report recurring issues to the quality manager.
- Addressing and discussing issues and proposed solutions with the quality manager
**Education, Skills & Qualifications**:
- Bachelor’s degree in any related field.
- Years of Experience**: 4 - 6 Years of experience**
- Valid driver’s license.
- Work under mínimal supervision and have excellent time management skills.
- Professional certification, such as **Six Sigma or Quality Auditor.**:
- Superb computer competence, including database management.
- Knowledge of quality assurance terminology, methods, and tools.
- Analytical, problem-solving, and decision-making skills.
- Good communication skills, both verbal and written.
- Strong attention to detail.
- Background in customer experience management.
- Excellent written and verbal communication skills in English.
- Demonstrated knowledge of testing best practices, version control practices, and defect management practices.
**Salary and Benefits**:
- Gross Salary Range**:9,000 - 13,000 LE**
- Bonus Scheme: 1 Month bonus based on evaluation - Paid quarterly
- Medical Insurance Coverage
- Social Insurance
Senior Quality Assurance Engineer
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Curenta is a digital health-tech startup changing the shape of long-term healthcare through medication delivery innovation. If you are excited to join an ultra-growth startup that is quadrupling its growth every month since the beginning, and enjoy the ride of changing the shape of industries, this job is for you.
**About the Job**:
QA engineer responsibilities include designing and implementing tests, debugging and defining corrective actions. You will also review system requirements and track quality assurance metrics
Ultimately, you should monitor all stages of software development to identify and resolve system malfunctions to meet quality standards.
**Responsibilities**:
- Plan, execute, and oversee inspection and testing of products to confirm quality and conformance to specifications and deliverables
- Assist operations in tracking, documenting, and reporting quality levels as well as CSR, environmental, and health and safety goals KPIs
- Analyze and investigate product complaints or reported quality issues to ensure resolution in accordance with company guidelines and external regulatory requirements
- Develop or update company procedures to ensure capture, investigation, and proper documentation of complaints
- Monitor risk-management procedures, and maintain problem logs for identifying and reporting issues to management and product development
- Provide training and support to the quality assurance team that includes systems, policies, procedures, and core processes
**Qualifications**:
- 3+ years of experience as Quality Assurance Engineer
- Superb computer competence, including database management
- Knowledge of quality assurance terminology, methods, and tools
- Experience with a variety of different testing techniques such as UI Testing, Automated Testing, Test Driven Development Strategies, and others.
- Having programming skills to automate test cases, is a plus
- Experience with automation testing tools like Selenium, JMeter,etc, is a plus
- Understanding of unit-testing, integration testing, acceptance testing, load testing, and performance testing
- Experience with web security technology
- Experience with software QA processes and tools like Testim, Autify, Kobiton, testRigor,etc, is preferred
- Excellent analytical, problem-solving, detail-oriented, and decision-making skills
- Demonstrated knowledge of testing best practices, version control practices, and defect management practices
- Understanding of Agile/Scrum methodology