MUST HAVE EXPERIENCE IN DRY AND LIQUID INJECTABLE PLANT
Key Responsibilities
- Laboratory Management: Oversee day-to-day operations of the QC lab, including testing and analysis (HPLC, GC, UV) for sterile and non-sterile products.
- Release & Compliance: Ensure timely batch release, including evaluating finished product Certificates of Analysis (COA) for sterility and potency.
- Regulatory Adherence: Ensure 100% adherence to Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
- Documentation & Investigations: Review/approve analytical data, specifications, and investigations into Out of Specification (OOS) and Out of Trend (OOT) results.
- Method & Equipment Validation: Support validation of analytical methods, calibration of lab instruments, and qualification of equipment.
- Sterility & Environment: Oversee environmental monitoring, sterility testing, and endotoxin tests to ensure injectable sterility.
- Leadership: Train, mentor, and manage QC staff in analytical techniques and regulatory updates.
Required Qualifications & Skills
- Education: BSc or MSc in Chemistry, Pharmacy, or Microbiology.
- Experience: 10–14 years of relevant pharmaceutical QC experience, with significant experience in sterile/injectable manufacturing plants.
- Technical Knowledge: Proficiency in HPLC, UV, GC, and sterility testing.
- Compliance Knowledge: Deep understanding of global regulatory standards and QMS.
- Specific Focus for Injectables
- The QC Manager for an injectable plant faces higher stakes regarding contamination; therefore, they specifically focus on
- sterile validation
- environmental monitoring data review & endotoxin analysis
Pay: Up to ₹100,000.00 per month
Work Location: In person
