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Associate Manufacturing Quality Assurance

2-6 years
Not Disclosed
10 Nov. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Hiring: Associate Manufacturing Quality Assurance

📍 Location: Vizag, India
💼 Job Type: Full-time
🆔 Job ID: 4944686
📅 Posted: 7 Days Ago


About Pfizer

Pfizer is committed to breakthroughs that change patients’ lives. Pfizer Global Supply (PGS) is responsible for manufacturing and distributing high-quality pharmaceutical products, ensuring patient safety through flexible and compliant quality systems.


Role Summary

The Manufacturing Quality Downstream Associate serves as the primary quality contact on the production floor, particularly in Terminal Sterilization, Visual Inspection, and Packaging operations. The role ensures compliance with cGMP standards, monitors manufacturing processes, and supports continuous improvement initiatives.


Key Responsibilities

Quality Oversight

  • Ensure cGMP compliance in Terminal Sterilization, Visual Inspection, and Packaging operations.

  • Maintain regulatory compliance in accordance with cGMP practices.

  • Ensure manufacturing policies and procedures align with Pfizer standards.

Operational Support

  • Review electronic batch records (eBR) and assess the impact of AMP exceptions with guidance from Sr. Associate or Sr. Team Leader.

  • Review batch reports and equipment audit trails.

  • Conduct Acceptable Quality Level (AQL) sampling, inspections in VIDT, batch record review, and release.

  • Perform batch start-up and end activities including sensor challenge tests and recipe review.

  • Conduct random process checks for Terminal Sterilization, Visual Inspection, and Packaging.

  • Perform daily walkthroughs and report observations to Sr. Team Leader.

  • Assess equipment breakdowns, equipment alarms, and quarterly alarm trends with technical support as needed.

Process Improvement

  • Identify gaps and participate in process and procedure simplification to reduce downtime and increase efficiency.

  • Apply troubleshooting skills to enhance manufacturing operations and support organizational goals.


Minimum Requirements

  • Experience: 2–6 years in Manufacturing Quality Assurance, Quality Assurance, or production within a pharmaceutical manufacturing facility.

  • Industry Knowledge: Sound understanding of pharmaceutical quality systems and current Good Manufacturing Practices (cGMP/GxP).

  • Skills:

    • Ability to work effectively in team environments across departments.

    • Strong written and oral communication skills.

    • Hands-on approach to problem-solving and process improvement.


Work Location

  • On Premise – Vizag, India


Equal Opportunity

Pfizer is an equal opportunity employer and complies with all applicable employment legislation in each jurisdiction in which it operates.


🔗 Apply Now: Pfizer Careers – Associate Manufacturing Quality Assurance