Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience as Pfizer Animal Health, we deliver quality medicines and vaccines, complemented by diagnostics products and genetics tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.
Post: Executive Quality Assurance
Job Description:
Job Responsibilities
- Handling of In-Process Quality Operations and IPQA team.
- Review of Batch Manufacturing Record (BMR) and Batch Packaging Records (BPR) and Batch Release activity.
- Handling of change controls, deviations, incidents, batch failure investigations, CAPA and market complaints.
- Preparation and review of Annual Product Reviews (APRs).
- Preparation and review of Quality Assurance (QA) and Validation related Standard Operating Procedures (SOP).
- Audit of vendors, self audits, preparation of audit reports and to ensure compliance.
- Preparation and maintenance of validation master plan, Calibration master plan, Validation/ Qualification Protocols and Summary reports.
- Preparation review and execution of process validation protocols and reports.
- Process validation for Tablet, Liquid oral and Injection products. Aseptic process simulation (media fill), validation of filtration, sterilization and depyrogenation processes.
- Planning of calibration activities of instruments and coordination with external agencies for timely calibration and related documentation.
- Strong knowledge on packaging validations and utilities (HVAC, Water, Compressed gas, Nitrogen and Area Qualifications) validations.
- GMP and validation training to peers and team members.
Education and Qualification
Essential: B. Pharma or M. Sc (Microbiology)
Desirable:
Exposure to USFDA, MHRA audits.
Strong communication and writing skills.
Local or nearby Haridwar region.
Exposure to Six Sigma, Total Quality Management (TQM) or Total Productivity Management (TPM) related activities
Work Experience
6 to 8 years of work experience in Quality Assurance and Validation related activities.
Skills and Competencies
Ability to handle a team and should have managerial skills.
Strong communication and convincing skills to inculcate the validation practices and understanding among the team members and peers.
Updated on current trends in QA and Validations
Additional Information:
Experience: 6-8 Year
Location: Haridwar
Job Ref: 10611688
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 31st Dec., 2013
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