Use Your Power for Purpose
At Pfizer, our purpose is to deliver breakthroughs that change patients’ lives. Your work will leverage cutting-edge design and process development capabilities to accelerate and deliver best-in-class medicines to patients globally. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your contributions will be vital in helping Pfizer achieve new milestones and make a global impact on patient health.
What You Will Achieve
In this role, you will:
Conduct qualitative and quantitative analyses of various compounds and biologics to determine their properties during chemical syntheses, fermentation, or drug product development
Utilize scientific judgment to adapt standard methods and techniques, drawing on prior experience and consulting with colleagues
Apply technical skills and knowledge proactively in projects, making decisions to resolve moderately complex problems, and receive instructions on complex problems with periodic review
Establish analytical procedures, interpret technical data, and develop scientific activities/projects to support team goals
Communicate progress, plans, requirements, and risks to senior analysts, managers, stakeholders in partner groups, and higher management through written reports and presentations
Actively participate and report progress in cross-functional project teams to meet customer expectations, project milestones, and Good Manufacturing Practices (cGMP) standards
Prepare and review technical documents, including validation protocols, analytical test procedures, investigation reports, and change controls, and support the development, qualification, validation, and transfer of cell-based and immunoassays for clinical development
Here Is What You Need (Minimum Requirements)
B-Tech / Pharmacy / Equivalent with at least 10 years of experience in Validation department specifically in CSV.
Manage routine and project validation activities to support site objectives.
Hands on experience on Equipment qualifications.
Ensure revalidations are performed within the established intervals.
Review of analogue inputs, analogue out puts, digital inputs and digital outputs checks.
DCS qualification protocol development.
Ensure computerized system of manufacturing equipment, automatic visual inspection, packing and sterilization process are validated in accordance with cGMP, corporate policies, procedures and as per the schedules.
Review validation data and final validation reports to ensure completeness and accuracy.
Evaluate existing validation packages for compliance to FDA guidance and Pfizer global validation procedures.
Partner & Review and approval of IQ/OQ/PQ activity and review of protocols.
Review and approve SOPs pertaining to Equipment qualification, operation and cleaning; Provide feedback if need be.
Interact with various external calibration agencies /vendors for procuring standard Instruments.
Share expertise with global validation teams and be recognized as an expert.
Ensure site meets benchmarks set by other global Pfizer sites and incorporate best practices within operations on site.
Influences senior management decisions that have an impact on business direction within Validation Team.
Partners with Pfizer network sites to accomplish Global validation objectives.
Interact with various external calibration agencies/ vendors for procuring standard instruments.
Share expertise with global validation teams and be recognized as an expert.
Ensure site meets benchmarks set by other global Pfizer sites and incorporate best practices within operations on site.
Understanding of pharmaceutical manufacturing, packaging, quality assurance operations.
Knowledge of validation principles and practices related to the following areas: manufacturing process, facility, equipment, instrument ,utility system, CSV systems and DCS system.
Conversant with design & working principles of key equipment used in sterile manufacturing —autoclave, tunnel, lyophilizer, homogenizers, Vail filling, filter integrity testing devices.
Well versed with TS process, computerized systems design and approval of the documents.
Experience in handling regulatory agency inspections at site.
Knowledge on the GAMP requirements,21CFR and ALCOA requirements.
Good document review and approval skills, with ability to identify issues, investigations and recommend actions.
Deviations handling and Investigations skills.
CCF handling and assessment skills.
Knowledge on ALCOA and data integrity principles.
Bonus Points If You Have (Preferred Requirements)
Audit exposure for FDA, MHRA,TGA,MCC etc
Exceptional interpersonal skills and a proven track record of teamwork
Experience with advanced analytical techniques and instrumentation
Effective verbal and written communication skills
Ability to interact effectively with peers and leaders as part of a multi-disciplinary team
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.