Sr. Officer

17 hours ago

Patas Pune Maharashtra, India Steribio Lifesciences Pvt Full time ₹ 12,00,000 - ₹ 19,20,000 per year

Job Title: Senior Officer – Quality Assurance

Department: Quality Assurance

Experience: 2 – 4 years LVP/SVP experience

Job Summary

The Senior Officer – QA will be responsible for managing quality systems such as Change Control, Deviations, Incidents, OOS, RCA, Audit Trail Review, Stability Studies, and APQR activities. The role ensures compliance with regulatory standards, timely documentation, and continuous improvement of QA processes.

Key Responsibilities1. Quality Systems Management

  • Review, initiate, and close Change Controls in compliance with SOPs and regulatory expectations.
  • Manage and investigate Deviations, Incidents, and OOT/OOS effectively with proper documentation.
  • Conduct Root Cause Analysis (RCA) and propose appropriate CAPAs.
  • Ensure timely monitoring and closure of CAPAs.

2. Stability Study Management

  • Plan and execute stability studies as per approved protocols.
  • Coordinate sample placement, testing, and data collection.
  • Review stability study reports and ensure data integrity.

3. APQR (Annual Product Quality Review)

  • Compile and review APQR data for all products.
  • Coordinate with production, QC, warehouse, and engineering for required inputs.
  • Ensure timely preparation and approval of APQR reports.

4. Audit Trail Review

  • Perform periodic audit trail reviews for QC instruments and systems.
  • Identify gaps, document observations, and ensure corrective actions are implemented.
  • Ensure compliance with ALCOA+ principles and data integrity standards.

5. Documentation & Compliance

  • Prepare, review, and approve QA documents (SOPs, qualification documents, protocols, reports).
  • Ensure compliance with GMP, GDP, and regulatory guidelines.
  • Support in risk assessments and data trending activities.

6. Audit Support

  • Participate in internal audits, external audits, and regulatory inspections.
  • Prepare documentation and evidence required for audits.
  • Coordinate closure of audit observations within timelines.

7. Cross-Functional Coordination

  • Work closely with Production, QC, Engineering, Warehouse, and other teams for QA requirements.
  • Provide guidance to junior QA team members on quality systems and documentation.

Required Skills & Competencies

  • Strong understanding of QMS processes and regulatory requirements.
  • Hands-on experience with Deviations, CAPA, OOS/OOT, Change Control, Stability Studies, and APQR.
  • Good knowledge of data integrity and audit trail principles.
  • Strong analytical, investigation, and documentation skills.
  • Proficient in MS Office and QA documentation software (if applicable).
  • Excellent communication and coordination abilities.
  • Attention to detail and compliance mindset.

Qualification

  • B.Pharm / M.Pharm / M.Sc / B.Sc (Science background).
  • 2–4 years of experience specifically in QA (QMS, documentation, and investigations).

Job Type: Full-time

Pay: ₹25, ₹40,000.00 per month

Work Location: In person

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