Quality Control ( QC) Executive / Manager

The QC Officer/Executive is responsible for ensuring that all products meet quality and safety standards before release. This includes testing of raw materials, in-process samples, and finished products in compliance with regulatory and company quality standards. The role requires strong analytical skills, attention to detail, and adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

• Conduct routine testing of raw materials, intermediates, and finished products using analytical and microbiological methods.
• Ensure compliance with GMP, GLP, ISO, and regulatory requirements.
• Maintain and calibrate laboratory instruments (e.g., HPLC, UV, GC, pH meter, balances).
• Prepare and review Standard Operating Procedures (SOPs), test methods, and specifications.
• Record and report analytical results accurately in laboratory notebooks or electronic systems.
• Participate in stability studies and ensure documentation as per regulatory norms.
• Support method validation, equipment qualification, and environmental monitoring activities.
• Investigate out-of-specification (OOS) and non-conformance (NC) results; assist in root cause analysis and CAPA implementation.
• Ensure laboratory safety, hygiene, and compliance with biosafety protocols.
• Collaborate with Quality Assurance (QA), Production, and R&D teams to resolve quality issues.

• Education: M.Sc. / B.Tech / M.Tech in Biotechnology, Microbiology, Biochemistry, or related Life Science discipline.
• Experience: 310 years in QC department of a biotech, vaccine, pharmaceutical, or animal health company.
• Knowledge: Analytical techniques (HPLC, UV, TLC, etc.), Microbiological testing (bioburden, sterility, endotoxin), Documentation and regulatory compliance (CFR, WHO, ISO, NABL), Understanding of biological and biotechnological products.

• Strong analytical and problem-solving skills
• Good documentation and data integrity practices
• Knowledge of GLP/GMP
• Attention to detail and accuracy
• Ability to work under minimal supervision
• Team collaboration and communication skills

• Accuracy and timeliness of analytical results
• Compliance with SOPs and regulatory standards
• Laboratory audit scores and CAPA closure timelines
• Equipment calibration and maintenance compliance
• Contribution to process improvement initiatives