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.
* Reviewing and approval the required SOPs related to chemical laboratory tasks and ensuring that these procedures are strictly followed during laboratory practices.
* Coaching and developing chemical laboratory colleagues to achieve high performance.
* Trouble Shooting for section problems
* 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.
* Supporting Validation analysis for newly developed test procedures.
* Execute Analytical laboratory investigation reports (ALIR) for out-of-specification FG results.
* Responsible for endorsement of GLP requirements during laboratory practices.
* Ensuring implementation of EHS measures/actions within QC laboratories.
* Coaching section colleagues with their improving projects and sponsoring their projects.
* Implements new programs, tests, methods, instrumentation and procedures by investigating alternatives; preparing proposals; monitoring progress.
* Supports QA with all CCRs and QARs related to the section.
* Stability tasks:
* Responsible for the stability studies of finished products and corresponding documentation to evaluate/support shelf life of product.
* Planning and executing for both Long-Term and accelerating stability testing.
* Planning and executing stability testing for Annual ongoing stability.
* Preparation of stability Balance Score Card (BSC)
* Managing all Stability resources efficiently.
* Responsible for stability equipment maintenance and supplier contact.
* Troubleshooting for section problems.
* Ensuring proper execution of calibration of stability chambers on time.
* Maintains laboratory supplies inventory required for Stability analysis by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
* Supporting regulatory dept. and compliance dept. with all their required documentations / actions.
* Supporting contractor in QC related activities, for evaluation of stability studies of outsourced products
* Support testing & evaluation of new products thought execution of stability studies
* Reviewing and approval of stability schedule, reports and trends
* Execute Analytical laboratory investigation reports (LIR) for out-of-specification stability results.
* Coaching section colleagues with their improving projects and sponsoring their projects.
* Supports QA with all CCRs and QARs related to the section.
* Review and Approval of the annual trending of LIR data
* Lead CV activities for Chemical part.
* Method validation:
* Perform and execute analytical method validation protocols.
* Develop new test methods and validate them.
* Coaching and Training analysts on AMV SOPs and PQS and ensure they are being followed.
* Communicate with compliance dept., regulatory dept. and MOH regarding all issues related to AMV and provide them with their required documents.
Compliance part:
* Ensure proper implementation of PQS requirements for QC laboratories, developing CAS reports.
* Stick to GLP and EHS requirements in QC laboratories.
* Complete &/or Participate in RFT projects in his area.
* Participate in the annual trending of the environmental monitoring, water analysis and LIR data analysis.
* Lead non-routine testing activities as cleaning validation, In-vitro dissolution profile activities, etc
Qualifications
BASIC QUALIFICATIONS
* University scientific degree.
* Minimum ‎4 years relevant experience in Quality Control.
* Experienced with QC Laboratory instruments, techniques and processes.
* PC literate with the following applications: MS Excel, Word, PowerPoint
* Ability to read English and interpret documents such as cGMP/ FDA regulations, standard operating procedures, and Pfizer corporate policy manuals.
PREFERRED QUALIFICATIONS
* Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
* Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complexproblems.
* Excellent attention to detail and time management skills.
* Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
* Six Sigma (Green belt) certified.
* Quality certificate is a plus.
PHYSICAL/MENTAL REQUIREMENTS
* Good command of English both written and spoken.
* Knowledgeable with interpersonal learning.
* Communication, teaching and coaching skills.
* Logic way of thinking
* Management and decision making skills
* High analytical skills
* Professional in reports writing.
* PC literate with the following applications: MS Excel, Word, PowerPoint

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Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

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