Table of Contents
Life Sciences QA Jobs at MSN Labs
QA Sterile (IPQA, AQA, Microbiology)
Company: MSN Laboratories (Adapt to local HR branding)
Location: Hyderabad, Telangana
Position Title: QA – Sterile (IPQA / AQA / Microbiology)
Experience: Minimum 2 years of relevant experience in sterile manufacturing / sterile quality roles
Employment Type: Full-time
Reporting To: QA Supervisor / QA Manager (Site)
Compensation (Hyderabad): INR 3.5 LPA – 5.5 LPA (CTC) — negotiable depending on skills, exact experience, and notice period. (Indicative range for candidates with ~2 years of sterile QA experience.)
Job Summary
We are seeking a detail-oriented and hands-on QA professional with experience in sterile products and processes. The role will cover three core areas: In-Process Quality Assurance (IPQA) for sterile manufacturing, Aseptic/Analytical Quality Assurance (AQA) activities related to documentation and compliance of analytical testing, and Microbiology oversight—environmental monitoring, sterility assurance, and contamination investigations. The candidate will support day-to-day sterile operations, compliance to cGMP, and continuous improvement initiatives.
Key Responsibilities
In-Process Quality Assurance (IPQA)
• Monitor and approve critical sterile manufacturing in-process activities (aseptic fills, lyophilization, sterile filtration, vial/ampoule/syringe assembly, etc.).
• Perform routine IPQA walkthroughs / inspections on the shop floor; verify adherence to batch documentation and SOPs.
• Review and sign-off on Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for assigned steps.
• Ensure proper gowning, personnel movement, and aseptic technique adherence during operations.
• Raise and follow-up on deviations, non-conformances, and CAPAs originating from IPQA checks.
• Support line clearance, changeover checks and cleaning validation / cleaning verification steps as applicable.
Aseptic / Analytical Quality Assurance (AQA)
• Review, control and authorize analytical test records (ATR), test methods and stability records in collaboration with the QC lab.
• Ensure compliance of analytical procedures and support release activities for in-process samples and finished sterile batches.
• Participate in method verification/transfer activities where required.
• Coordinate with QC for investigation of OOS/OOT results related to sterile products and ensure proper documentation and trend analysis.
Microbiology & Environmental Monitoring
• Execute and oversee environmental monitoring (EM) program: settle plates, active air monitoring, surface monitoring, personnel monitoring, and viable/non-viable monitoring follow-ups.
• Review EM trends, perform data analysis and flag excursions; recommend corrective actions and process improvements.
• Supervise sterility testing workflows and coordinate with Microbiology/QC teams for investigations.
• Lead contamination investigations (root cause analysis) for sterile failures, breaches, or incidents and ensure timely CAPA closures.
• Ensure hygiene and microbial control measures for utilities and critical equipment (WFI, compressed air, HVAC zones) are maintained.
Compliance, Documentation & Continuous Improvement
• Maintain and update SOPs, work instructions, and quality records related to sterile operations.
• Support internal and external audits — prepare documentation, respond to findings, and implement corrective actions.
• Train production personnel on aseptic techniques, gowning, hygiene, and current GMP requirements.
• Participate in qualification and validation activities (e.g., aseptic process simulation/media fills, equipment qualification support).
• Drive continuous improvement projects focused on reducing deviations, contamination events and improving yield.
Qualifications & Skills
Minimum Education: B.Sc. / M.Sc. in Microbiology / Biotechnology / Pharmacy / Life Sciences or equivalent.
Experience: At least 2 years of direct experience in a sterile manufacturing environment with exposure to IPQA, EM programs and microbiology investigations.
Technical Skills & Knowledge:
-
Practical knowledge of cGMP for sterile products and aseptic processing.
-
Hands-on experience with environmental monitoring systems and microbial testing techniques.
-
Familiarity with media fills / aseptic process simulations and sterility assurance practices.
-
Understanding of analytical testing and review processes (AQA) is preferred.
-
Experience with deviation management, CAPA, change control and investigation techniques (root cause analysis).
-
Good documentation skills and knowledge of BMR/BPR/ATR review and sign-off processes.
Behavioral & Soft Skills:
-
Strong attention to detail and observational skills
-
Good communication (written & verbal) and teamwork
-
Problem-solving mindset and ability to work under pressure
-
Ability to train and influence production staff on compliance matters
Key Performance Indicators (KPIs)
• Reduction in EM excursions and microbial contamination incidents.
• Timely closure of batch reviews and deviation investigations (TAT adherence).
• Compliance rate during IPQA walkthroughs and audits.
• Number of successful media fills and validation milestones achieved without major observations.
Interview Mode:
Direct interview – Walk-in interview / physical interview
