Associate Manager - Quality Assurance (Batch release)
Pfizer · Vizag, India
QualityFull-timeCompany career page
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Role summary
Associate Manager in Quality Assurance focused on batch release operations at a pharmaceutical manufacturing facility. Responsible for batch record audits, expiration date verification, investigation closure, and GMP/GDP compliance to ensure product safety and quality.
What they're looking for
- B.Pharma, M.Pharma, or MSc degree with 8-10 years pharmaceutical manufacturing/quality experience
- Sterile injectable manufacturing experience
- Strong technical writing, communication, and presentation skills
- Proficiency in Microsoft Office, Microsoft Project, and statistical software
- Experience conducting and participating in audits and inspections
- Knowledge of SAP, gLIMS, and AMPS systems preferred
What you'll be doing
- Complete and approve electronic and manual batch record audit items per policy
- Verify product expiration dates align with marketing authorization requirements
- Track closure of investigations and manage batch dispositions
- Monitor quality restrictions and product holds across batches
- Coordinate with plant departments on batch accumulation, review, and manufacturing lot release
Privacy & handoff
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