Validation Manager
GSK
Total years of experience :14 years, 5 Months
• Develops, review and approve validation documentation for site projects as per GSK policies & regulatory guidelines
• Coordinates validation activities with other site departments
• Participate inter-GSK site & GSK functions project & activities
• Liaises with departments with validation status/requirements
• Assists with New Products manufacturing processes - applies knowledge & experience
• Responsible for governing system validation status by review and approve site validation review plans
• Assist in the implementation of Product Life Cycle management through Process Validation & Continued Process Verification
• Conduct site staffs’ validation training as required
• Develop Validation department KPIs to measure performance, Providing necessary metrics on a monthly basis for reporting to management board
• Participating in section audits from a disclosure point of view, to ensure effective CAPA is applied where required
• Responsible for identifying risks and escalate to risk management process owner, develop risk mitigation plan and monitor the implementation plan
• Lead, oversight & communicate change management process & CCRs actions follow up
• Regulatory inspection readiness team member, responsible for quality preparedness plans
• Lead & manage change & compliance activities for handling & producing medical devises/combination products at site
• GDP site responsible
• Site training lead, responsible for oversight of training activities for all site colleagues
- Manage internal audit program
- Facility inspection walkthroughs responsible
- Assessing emerging regulatory expectations/impact of inspections at other sites
- Site inspection readiness
- Point of contact for responses to corporate/governmental audit observations
- oversight of regulatory commitments
- Manage validation programs during site startup phase & Saudi FDA inspection with cross functional teams of different operation groups
- Review, communicate and maintain commissioning and qualification plans, in addition to computerized systems validation plans (CSV)
- Review & communicate commissioning & qualification protocols for facilities, utilities & equipment protocols in preparation for site startup
- Manage all packaging validation activities after Saudi FDA site approval
- Training for newly hired team members for cGMP, GDP, validation activities
- EMA accreditation preparation team member, responsible for all validation related activity
- Manage all technical documents revision, reissuing.
- Preparing validation master plan
- computerized equipments system validation responsible
- ERP validation responsible
- Designing validation protocols both process & cleaning ones
- Supervising & conducting both process & cleaning validation activities
- Preparation & implementation of performance qualifications for various production equipment
- EMA accreditation preparation team member, responsible for all validation related activity
- Manage all technical documents revision, reissuing.
- CAPA responsible
- supplier audit team member
- Iso 9001 Audit team member
- Preparing validation master plan
- computerized equipments system validation responsible(SCADA & PLC based equipments)
- ERP validation responsible
- Designing validation protocols both process & cleaning ones
- Supervising & conducting both process & cleaning validation activities
- Preparation & implementation of performance qualifications for various production equipment
- Part of annual product review preparation team for various products
- Member of internal audit team
Master Degree in Quality Management
BSc of Pharmacy