Investigation Lead - Microbiology
- Pfizer
- 3 - 6 years
- Visakhapatnam
- 5 years ago
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Job Description
- To ensure the laboratory functions are in line with the current cGMP requirements. To ensure the compliance to 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 overview on 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 trainings 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.
- #LI - PFE
Job Classification
Industry: Construction, Engineering, Cement, MetalsFunctional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time
Education
Under Graduation: B.Tech/B.E. in ComputersPost Graduation: Post Graduation Not Required
Doctorate: Any Doctorate in Any Specialization, Doctorate Not Required
Contact Details:
Company: PfizerLocation(s): Visakhapatnam
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Keyskills: Housekeeping Waste management Manager Quality Assurance Finished products Microbiology Compliance Packaging Investigation Environmental monitoring Auditing
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Pfizer
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We re looking for new talent to join our global community, to unearth new innovative therapies that make the world a he...
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