Quality Control Supervisor

2 weeks ago

المملكة العربية السعودية, Saudi Arabia Pfizer Full time

Microbiology Lab tasks (Micro):
- Manage the Microbiological laboratory- Perform analysis of all microbiology tests analysis.
- Reviewing the Analytical Method Transfer Exercise (AMTE) results from local (new analysts, new test procedures) and from labs in other companies and/or countries and supporting them.
- Responsible for endorsement of GLP and EHS requirements and Control the GMP documents regarding microbiological laboratory.
- Troubleshooting for section problems and from labs in other companies outsourcing manufacturing.
- Facilitate all the equipment, reagents, media, and instrument necessary for performing the microbiological analysis and tests.
- Participate in the Process validation regarding microbiological analysis
- Prepare and supervise the performance of the environmental monitoring programs of the Non-sterile area, and Record, evaluate and trend the environmental monitoring data.
- Prepare and supervise the performance of the water monitoring programs of Plant and Record, evaluate and trend Water data.
- Training the analysts on the implementation of current new SOPs, Standard Test Procedures (MCD) and new techniques in the analysis. Document and approve the training documents.
- Coaching and developing Microbiological laboratory colleagues to achieve high performance.
- Executing micro testing required for stability programs for both ongoing and accelerating stability testing.
- Perform the microbiological laboratory investigation in case of out of specification results are occurred with microbiological laboratory analyst.
- Training the new microbiological analyst in the microbiological laboratory and co-ordinate with the Quality Control manager the Technology transfer for both the new analyst and the new test procedure.
- Prepare the SOP’s and validation protocol necessary for the microbiological laboratory activity and ensuring that these procedures are strictly followed during laboratory practices.
- Follow up on all plans related to Data Integrity.
- Responsible for implementation of all systems that support Data Integrity requirements.
- Responsible for ordering of micro laboratory needs.
- Implementing the PQS requirements regarding the Microbiological laboratory.
- Complete &/or Participate in RFT projects in his area.
- Responsible for the annual/quarter trending of the environmental monitoring, participating in water analysis and LIR data analysis.
- Maintains laboratory equipment performance by establishing quality standards, developing
- operations and quality procedures; ensuring staff compliance; certifying instrument performance.
- arranging equipment replacement, service, and repair
- Participate in QC resource planning including preparation of budgets and monitoring budget adherence with QC manager.
- Reviewing and approval of finished products analytical release documents.
- Reviewing and approval of semifinished products from contractors.
- Follow-up on all QC related actions including gQTS PRs as LIRs, RAACs, CCRs, QARs, CAPA and action items to ensure adherence to the scheduled due dates.
- Responsible for computerized systems as Empower 3 software, its validation and maintenance.
- Act as Admin for all QC systems.
- Responsible for managing data loggers monitoring, downloading and reviewing
- Lead CV activities for micro parts.
- Perform and execute analytical method validation protocols for microbiology.
- Develop new test methods and validate them for microbiology.

And/Or- Finished Goods tasks (FG):
- Responsible for the finished goods laboratory functions including in-process materials and corresponding documentation to support the timely disposition of product.
- Managing all FG laboratory resources efficiently, responsible for all aspects of the laboratory including equipment, employees, supplies, software and documentation.
- Coordinating schedule with other departments (Planning, Production).
- Supervise operational requirements by scheduling and assigning employees, following up on work results.
- Being the site coordinator for reference standards.
- Maintains FG laboratory equipment performance by establishing quality standards; developing operations and quality procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair
- Maintains laboratory supplies inventory required for FG analysis by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
- Supporting outsource manufacturing department, for manufacturing/release of outsourcedproducts
- Supporting validation department in execution of process validation activities and cleaning validation
- Reviewing and approval of finished products release documents (or designee)
- Training the analysts on the implementation of current new SOPs, Standard Test Procedures (STPs) and new techniques in the analysis. Document and approve the training documents.

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