3 Risk Management jobs in Egypt
Risk Management & Inspection Readiness QA Specialist
Sanofi
Posted today
Job Viewed
Job Description
KEY RESPONSIBILITIES AND DUTIES:
- Contamination Control Strategy (For Non-sterile & Sterile):
- Perform activities & responsibilities of Contamination Control for the site.
- Contamination control strategy implementation on-site.
- Perform process observation and GEMBA walks on-site to raise improvements needed in the different processes.
- Quality Risk Management
- Execution of risk assessment of different processes.
- Follow up implementation of quality risk assessments master plan.
- Act as facilitator for risk assessment process on-site.
- Support in investigations of different processes with risk management methodology.
- Global Quality Documents Gap analysis
- Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis
- Perform gap analysis for the assigned documents.
- Inspection Readiness (SQRs, Inspections and Audits Management).
- Ensure inspection readiness according to the IR Sanofi handbook.
- Create satisfactory action plan for the communicated memos, SQR reports, and received audits or inspections by the concerned area responsible.
- Respect of company values, code of ethics & social charter.
- Perform other duties as assigned.
- HSE Responsibilities:
- Ensures HSE approval on any SOP that requires certain HSE precautions.
- Ensures HSE approval on any change.
- Follow the laboratory safety procedures
- Commitment to the appropriate PPE use.
- Follow the approved HSE policy and requirements.
- Following the statutory legislation concerning Health, Safety and environmental law.
- Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
- HSE Responsibilities in case joining HSE Excellence team:
- Facilitate and guide the employees to implement the HSE & Energy Policies.
- Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
- Ensure from complying with all legal and Sanofi-Aventis requirements.
- Lead his/her team to implement the HSE & EnMS PASS.
- Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
- Report any accidents/incidents in his/her area to the HSE department.
- Lead his/her team for investigate accidents/incidents to define the root cause.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
- Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
- Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
- Define and control the required PPE’s for his/her area.
- Define the list of CMR and its operational control for Quality labs and production areas.
- Control the first aid kits in his/her area.
- Leading his/her team for control the significant hazards /aspects and Energy use.
- Others:
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter.
JOB-HOLDER’s ENTRY REQUIREMENTS
_:_
**Education**:
- Bachelor of Pharmaceutical Sciences.
Related Experience:
- From 3 to 5 years in non-sterile different dosage forms specifically Solid & Liquids manufacturing (QA/Production).
- Knowledge of regulatory requirements for non-sterile manufacturing.
- Sterile manufacturing knowledge & experience is an asset.
- Risk assessment process knowledge & practicing is an asset.
Special Knowledge/Skills:
- Good communication & Presentation skills.
- Planning & organizing skills
- Problem solving skills.
- Report writing skills.
- Ability to co-ordinate several inter-departmental activities.
- Good command of MS Word, Excel & Power Point.
- Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
- Contamination Control Strategy (For Non-sterile & Sterile):
- Perform activities & responsibilities of Contamination Control for the site.
- Contamination control strategy implementation on-site.
- Perform process observation and GEMBA walks on-site to raise improvements needed in the different processes.
- Quality Risk Management
- Execution of risk assessment of different processes.
- Follow up implementation of quality risk assessments master plan.
- Act as facilitator for risk assessment process on-site.
- Support in investigations of different processes with risk management methodology.
- Global Quality Documents Gap analysis
- Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis
- Perform gap analysis for the assigned documents.
- Inspection Readiness (SQRs, Inspections and Audits Management).
- Ensure inspection readiness according to the IR Sanofi handbook.
- Create satisfactory action plan for the communicated memos, SQR reports, and received audits or inspections by the concerned area responsible.
- Respect of company values, code of ethics & social charter.
- Perform other duties as assigned.
- HSE Responsibilities:
- Ensures HSE approval on any SOP that requires certain HSE precautions.
- Ensures HSE approval on any change.
- Follow the laboratory safety procedures
- Commitment to the appropriate PPE use.
- Follow the approved HSE policy and requirements.
- Following the statutory legislation concerning Health, Safety and environmental law.
- Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.
- HSE Responsibilities in case joining HSE Excellence team:
- Facilitate and guide the employees to implement the HSE & Energy Policies.
- Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
- Ensure from complying with all legal and Sanofi-Aventis requirements.
- Lead his/her team to implement the HSE & EnMS PASS.
- Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
- Report any accidents/incidents in his/her area to the HSE department.
- Lead his/her team for investigate accidents/incidents to define the root cause.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
- Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
- Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
- Define and control the required PPE’s for his/her area.
- Define the list of CMR and its operational control for Quality labs and production areas.
- Control the first aid kits in his/her area.
- Leading his/her team for control the significant hazards /aspects and Energy use.
- Others:
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter.
JOB-HOLDER’s ENTRY REQUIREMENTS
_:_
**Education**:
- Bachelor of Pharmaceutical Sciences.
Related Experience:
- From 3 to 5 years in non-sterile different dosage forms specifically Solid & Liquids manufacturing (QA/Production).
- Knowledge of regulatory requirements for non-sterile manufacturing.
- Sterile manufacturing knowledge & experience is an asset.
- Risk assessment process knowledge & practicing is an asset.
Special Knowledge/Skills:
- Good communication & Presentation skills.
- Planning & organizing skills
- Problem solving skills.
- Report writing skills.
- Ability to co-ordinate several inter-departmental activities.
- Good command of MS Word, Excel & Power Point.
- Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
This advertiser has chosen not to accept applicants from your region.
0
Hse/ Risk Assessment Quality Engineer
Antal International
Posted today
Job Viewed
Job Description
One of the reputable pharmaceutical industrial companies is looking for a professional HSE/ Risk Assessment & Quality Engineer who is expert in establishing risk analysis plans, handling suppliers & sub-contractors and products registration.
**Key Responsibilities**:
- The Risk Assessment & Quality Engineer is responsible for setting policies and procedures for the establishment of plans for risk analysis concerned with the company's products, suppliers and sub-contractors.
- You'll be accountable for recommending and implementing risk management solutions with respect to regulatory documentation and submissions and making sure that Risk Analysis becomes an integral part of the company's Quality Management System.
- One of your main duties is to ensure that Good Health and Safety practices are implemented and maintained in production activities.
**Key Requirements**:
- A university degree in Quality, Engineering or a scientific discipline.
- Min. of 5 years of experience in Quality Operations, Qualifications & Validation, Quality Systems and Quality Risk Management.
- Min. of 5 years of experience in **_biopharmaceutical business_** industry with full working knowledge of ICH Q9, ICH Q10 and the FDA, WHO and EMA requirements for the manufacture and control of pharmaceuticals and biological products and risk analysis.
- The right caliber for the role must have a proven experience in root cause analysis in manufacturing and control issue troubleshooting and understanding of regulatory processes for vaccines.
- Holding certifications in HSE is a huge plus.
- Excellent communication skills & Ability to work effectively and efficiently across company functional areas and with external third parties.
- Fluent English is a MUST.
**Key Responsibilities**:
- The Risk Assessment & Quality Engineer is responsible for setting policies and procedures for the establishment of plans for risk analysis concerned with the company's products, suppliers and sub-contractors.
- You'll be accountable for recommending and implementing risk management solutions with respect to regulatory documentation and submissions and making sure that Risk Analysis becomes an integral part of the company's Quality Management System.
- One of your main duties is to ensure that Good Health and Safety practices are implemented and maintained in production activities.
**Key Requirements**:
- A university degree in Quality, Engineering or a scientific discipline.
- Min. of 5 years of experience in Quality Operations, Qualifications & Validation, Quality Systems and Quality Risk Management.
- Min. of 5 years of experience in **_biopharmaceutical business_** industry with full working knowledge of ICH Q9, ICH Q10 and the FDA, WHO and EMA requirements for the manufacture and control of pharmaceuticals and biological products and risk analysis.
- The right caliber for the role must have a proven experience in root cause analysis in manufacturing and control issue troubleshooting and understanding of regulatory processes for vaccines.
- Holding certifications in HSE is a huge plus.
- Excellent communication skills & Ability to work effectively and efficiently across company functional areas and with external third parties.
- Fluent English is a MUST.
This advertiser has chosen not to accept applicants from your region.
1
Security Risk and Compliance Management, Technical
Mansoura
Vodafone
Posted today
Job Viewed
Job Description
**Role purpose**:
- The Security and Compliance SME Works closely with the Global Office IT Security & Compliance Manager to ensure that Global Office IT meets security and compliance requirements.
**Key accountabilities and decision ownership**:
Security Governance and Compliance:
- Identify, assess, and manage Global Office IT’s ability to meet all security and compliance requirements.
- Prepare road map for improvement (enhanced security posture, operational processes/procedures, etc.) based on gaps identified.
- Engage with Global Office IT domains to drive initiatives to close the gaps.
- Enforce Security Controls as per applicable standards & Regulations (ISO, GDPR, etc.)
- Internal Audit of ISO 27001 controls
- Publish compliance reports Other:
- Willing to work according to the German calendar in terms of the weekends and the public holidays according to the shift schedule
- Represent Security and Compliance function topics in Office IT-related team meetings - Core competencies, knowledge, and experience: IT Auditor (Internal/External)
- ISO 27001 (Lead implementer/ Lead Auditor) certified or experience in implementing ISO 27001 framework
- Experience with SOX testing and IT General Controls (ITGC) framework
- Preferably Certified Information Systems Auditor (CISA) and/or Certified Information Systems Security Professional (CISSP) professional
- IT Risk assessment, risk management experience
- Working experience in Data Privacy and Data Security frameworks and controls (encryption, GDPR, PKI, etc.) preferable.
- Working experience in Cyber Security (Anti-virus, Patching, Vulnerability Management, etc.) is preferable
**Must have technical/professional qualifications**:
- Education:_
- BSC in Computer Engineering or Computer Science
- Work Experience:_
- 6+ years of experience in IT/Information Security
- ISO27001 knowledge is a must
- English fluency is a must
movewithus #_VOIS
- The Security and Compliance SME Works closely with the Global Office IT Security & Compliance Manager to ensure that Global Office IT meets security and compliance requirements.
**Key accountabilities and decision ownership**:
Security Governance and Compliance:
- Identify, assess, and manage Global Office IT’s ability to meet all security and compliance requirements.
- Prepare road map for improvement (enhanced security posture, operational processes/procedures, etc.) based on gaps identified.
- Engage with Global Office IT domains to drive initiatives to close the gaps.
- Enforce Security Controls as per applicable standards & Regulations (ISO, GDPR, etc.)
- Internal Audit of ISO 27001 controls
- Publish compliance reports Other:
- Willing to work according to the German calendar in terms of the weekends and the public holidays according to the shift schedule
- Represent Security and Compliance function topics in Office IT-related team meetings - Core competencies, knowledge, and experience: IT Auditor (Internal/External)
- ISO 27001 (Lead implementer/ Lead Auditor) certified or experience in implementing ISO 27001 framework
- Experience with SOX testing and IT General Controls (ITGC) framework
- Preferably Certified Information Systems Auditor (CISA) and/or Certified Information Systems Security Professional (CISSP) professional
- IT Risk assessment, risk management experience
- Working experience in Data Privacy and Data Security frameworks and controls (encryption, GDPR, PKI, etc.) preferable.
- Working experience in Cyber Security (Anti-virus, Patching, Vulnerability Management, etc.) is preferable
**Must have technical/professional qualifications**:
- Education:_
- BSC in Computer Engineering or Computer Science
- Work Experience:_
- 6+ years of experience in IT/Information Security
- ISO27001 knowledge is a must
- English fluency is a must
movewithus #_VOIS
This advertiser has chosen not to accept applicants from your region.
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