Quality Assurance Officer

Quality Assurance Officer is responsible for ensuring that all manufacturing and quality-related activities comply with Good Manufacturing Practices (GMP), regulatory guidelines, and company quality standards. The role involves reviewing documentation, monitoring production processes, conducting internal audits, and supporting continuous improvement to maintain product quality and regulatory compliance.

Key Responsibilities:

• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and other related documents before batch release.
• Monitor in-process activities in the production and packing areas to ensure compliance with GMP and SOPs.
• Participate in line clearance, in-process checks, and documentation verification.
• Review and ensure implementation of Standard Operating Procedures (SOPs) and update them as required.
• Handle and document deviations, change controls, CAPA, and OOS/OOT investigations in coordination with relevant departments.
• Conduct and support internal audits, self-inspections, and vendor audits to ensure compliance with quality standards.
• Ensure the proper qualification and calibration of equipment, instruments, and utilities.
• Participate in training programs and ensure proper documentation of staff training records.
• Assist in validation and qualification activities (process, cleaning, equipment, and analytical methods).
• Ensure data integrity and documentation accuracy in all QA operations.
• Support preparation for regulatory and customer audits (e.g., WHO, USFDA, MHRA, GMP).
• Promote a culture of continuous improvement and compliance within the organization.

Qualifications & Experience:

• Education: B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, or related field).
• Experience: Around 3 years of experience in Quality Assurance within a pharmaceutical formulation / API / sterile manufacturing unit.
• Technical Skills:
• Strong understanding of GMP, GLP, and regulatory requirements (WHO, USFDA, EU-GMP).
• Experience with documentation control, CAPA, change control, and deviation handling.
• Familiarity with validation and qualification protocols.
• Soft Skills:
• Excellent attention to detail and documentation accuracy.
• Strong communication and coordination skills.
• Ability to work cross-functionally with production, QC, and maintenance teams.
• Good analytical and problem-solving skills.

Key Performance Indicators (KPIs):

• Timely review and approval of production and quality documents.
• Number of deviations/CAPA closed within target timelines.
• Compliance rate during internal and external audits.
• Reduction in documentation errors and non-conformities.
• Adherence to GMP and company quality systems.

Job Type: Full-time

Pay: ₹15, ₹35,000.00 per month

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Work Location: In person