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Designation: Investigation Lead – Microbiology
Location: Vizag, Andhra Pradesh
Job Description:
- To ensure the laboratory functions are in line with the current cGMP requirements. To ensure compliance with quality/safety/cGMP procedures.
- To support regulatory, corporate and customer (if applicable) audits and to provide timely response and compliance to the audit findings.
- To participate incorporate discussions on Microbiology related activities and provide an overview of the site procedures.
- To provide necessary resources for smooth and timely execution of analysis and laboratory functions
- To identify the manpower needs and to recruit the people with adequate competencies. To induct the new joiners as per the procedures
- To ensure adherence to Good Documentation Practices. To monitor documentation errors and to create awareness among the teams through training and periodic interactions for minimization of the same
- To review investigations for their adequacy and to suggest additional investigation areas if not adequate. Also to establish and implement effective CAPA’s.
- Review, approve and implement CAPA’s, change controls and site quality and improvement initiatives
- To review/approve method validation/verification protocols and all other miscellaneous studies.
- To coordinate with cross-functional teams (CFT’s) for any unresolved issues and to resolve,
- To escalate any unresolved quality/resource-related issues to the next level
- To participate/facilitate cross-functional teams for investigations and provide oversight on microbiology aspects to the investigation teams
- Creating quality/compliance/safety awareness among the team members through periodic team meetings
- To keep up to date with changes in the pharmacopeia/ regulations/guidelines and cascade the same to the -teams for awareness and to organize the creation/revision of the laboratory procedures in line with the changes for compliance
- Review and approval of training modules and to ensure that a robust analyst qualification program is in place and maintained.
- To monitor/ participate in the media fills and in media fill failure investigations (if applicable).
- To review and approve SOP, Specification, Validation protocols and Worksheets
- To approve or reject the starting materials, packaging materials, intermediate, bulk and finished products
- Ensure that a qualification, maintenance, and calibration program is in place and adhered to.
- Ensure that housekeeping and laboratory facilities are maintained in accordance with current standards
- Ensure that environmental monitoring systems are in place and maintained for all classified areas, utilities (water, pure steam, and gasses) and pure steam at the Vizag facility.
- Ensure waste management of Biological, toxic and hazardous water materials
- Ensure approved contract testing laboratories are used for all analysis activities.
- Ensure that procedures are maintained for the storage, handling, and destruction of microbial culture.
Department: Quality Assurance and Control
Qualification: Appropriately Qualified
Experience: Currently working in Same Capacity/Post
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