Pfizer Microbiology Investigation Lead Job – Apply Online
Pfizer Microbiology Investigation Lead Job – Apply Online. Pfizer is hiring Microbiology candidates for Investigation Lead – Microbiology vacancy. Interested and eligible applicants can check out all of the details on the same below:
Pfizer Vacancy Details
Job Title: Investigation Lead – Microbiology
Job ID: 4784431
Location of Pfizer Vacancy: India – Vizag
Job Description:
- To ensure the lab functions are in line with the current cGMP requirements. To guarantee 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 in corporate 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 lab functions.
- To identify the manpower needs and to recruit the people with adequate competencies.
- To induct the new joiners as per the procedures.
- To guarantee adherence to Excellent Documentation Practices. To monitor documentation errors and to create awareness among the teams via training and periodic interactions for minimization of the same.
- To review investigations for their adequacy and to recommend additional investigation areas if not adequate. Additionally to develop 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 various other miscellaneous studies.
- To coordinate with cross-functional teams (CFT’s) for any kind of unresolved issues and to resolve,
- To escalate any kind of 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 pharmacopoeia/ 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 guarantee 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 lab facilities are maintained according to current standards.
- Guarantee 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 labs are used for all analysis activities.
- Ensure that procedures are maintained for the storage, handling and destruction of microbial culture.
- #LI- PFE.
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