QA Officer

3 hours ago

Patas Pune Maharashtra, India Steribio Lifesciences Pvt Full time ₹ 3,00,000 - ₹ 4,80,000 per year

Job Title: Officer – Quality Assurance

Department: Quality Assurance

Experience: 2 – 4 years - LVP/SVP experience

Job Summary

The QA Officer will be responsible for supporting key Quality Assurance activities including APQR preparation, stability study coordination, vendor qualification, and equipment qualification. The role ensures compliance with GMP standards, accurate documentation, and cross-department coordination for quality-related processes.

Key Responsibilities1. Annual Product Quality Review (APQR)

  • Collect and compile APQR data from Production, QC, Warehouse, and Engineering.
  • Prepare APQR reports as per regulatory and internal requirements.
  • Track timelines and ensure timely completion and approval of APQRs.
  • Identify trends and support improvement activities.

2. Stability Studies

  • Coordinate stability sample planning, placement, and withdrawal.
  • Review stability protocols and ensure execution as per approved procedures.
  • Liaise with QC for testing and trending of stability data.
  • Maintain stability records and ensure regulatory compliance.

3. Vendor Qualification

  • Assist in vendor evaluation through document review, questionnaires, and audits.
  • Maintain approved vendor lists and qualification records.
  • Coordinate with Procurement, QC, and relevant departments for vendor approvals.
  • Ensure timely requalification as per defined schedules.

4. Equipment Qualification

  • Support qualification activities (IQ/OQ/PQ) for production, QC, and utility equipment.
  • Review qualification protocols, reports, and related documentation.
  • Coordinate with Engineering and QC for equipment readiness and compliance.
  • Maintain qualification status and documentation as per regulatory norms.

5. Documentation & Compliance

  • Review and prepare SOPs, formats, and qualification documents.
  • Ensure compliance with GMP, GDP, and company quality systems.
  • Support audits (internal/external) by providing required documents.
  • Maintain accurate records in line with data integrity principles (ALCOA+).

Required Skills & Competencies

  • Strong understanding of APQR, stability programs, qualification processes, and GMP.
  • Good documentation and analytical skills.
  • Knowledge of quality systems and regulatory guidelines.
  • Proficiency in MS Office (Excel, Word).
  • Coordination and communication skills.
  • Eye for detail and compliance-oriented mindset.

Qualification

  • B.Pharm / M.Pharm / B.Sc / M.Sc (Science background).
  • 2–4 years of experience specifically in Quality Assurance.

Job Type: Full-time

Pay: ₹25, ₹40,000.00 per month

Benefits:

  • Provident Fund

Work Location: In person

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