Position: Sr. Officer - QA
Location: Ekalbara
Qualification: M.Sc (Chemistry / Microbiology / Biotechnology or relevant field)
Experience: 2–5 Years
Salary: ₹3–6 LPA
Industry: Pharmaceutical / API Manufacturing
Job Summary
We are seeking a detail-oriented and experienced Sr. Officer - Quality Assurance (QA) to join our QA team. The ideal candidate should have experience in API manufacturing and documentation activities, ensuring compliance with GMP, regulatory requirements, and quality standards.
Key Responsibilities
Review and approve GMP documents, SOPs, BMRs, BPRs, protocols, and reports.
Handle QA documentation activities and maintain records as per regulatory requirements.
Monitor compliance with cGMP, GDP, and company quality systems.
Perform line clearance, process verification, and shop-floor QA activities.
Review deviations, change controls, CAPA, incidents, and investigations.
Support qualification and validation activities.
Conduct internal audits and ensure audit compliance.
Coordinate with Production, QC, and other departments for quality-related activities.
Ensure proper documentation control and archival management.
Participate in regulatory inspections and customer audits.
Required Skills
Experience in API manufacturing quality assurance.
Strong knowledge of GMP, cGMP, GDP, and pharmaceutical regulations.
Hands-on experience in QA documentation and document control.
Good understanding of deviations, CAPA, change control, and audit management.
Proficiency in MS Office and documentation systems.
Good communication and interpersonal skills.
Preferred Candidate Profile
M.Sc with 2–5 years of QA experience in the pharmaceutical/API industry.
Experience in handling QA documentation and compliance activities.
Ability to work independently and coordinate with cross-functional teams.
Knowledge of regulatory requirements and quality management systems.
Pay: ₹300,000.00 - ₹600,000.00 per year
Work Location: In person
