AGM/DGM/GM - Quality Control (Sterile Injectables)

3 days ago

Hyderabad, Telangana, India Anthea Pharma Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Summary:

Responsible for leading all Quality Control (QC) activities for sterile injectable products. This includes ensuring cGMP compliance, timely testing of materials and products, method validations, and lab readiness for audits and inspections.

Key Responsibilities:

  • Oversee day-to-day QC lab operations for sterile injectables (raw materials, in-process, finished product, and stability samples).
  • Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, EMA), and internal quality standards.
  • Review and approve SOPs, methods (STP, GTP), specifications, protocols, and validation/transfer documents.
  • Manage method validation, verification, and transfers for drug substances, products, excipients, and packaging.
  • Maintain lab equipment in calibrated and qualified condition.
  • Lead and develop QC team through training, analyst qualification, and performance management.
  • Support investigations (OOS, OOT, deviations) and ensure timely closure with proper CAPA.
  • Ensure lab audit readiness and actively participate in regulatory/customer inspections.
  • Coordinate with cross-functional teams for smooth QC support in manufacturing operations.

Qualifications, Experience & Key Skills Required:

  • M. Pharma / M. Sc. in Pharmaceutical Sciences with 15-20 years in Quality Control within the pharmaceutical industry, with at least 10 years in sterile injectable manufacturing and in a senior leadership role.
  • Strong understanding of cGMP, GLP, ICH guidelines, and global regulatory expectations (USFDA, MHRA, EMA, WHO, etc.).
  • Proven experience in analytical method validation, instrumental techniques (HPLC, GC, UV, etc.), and data integrity compliance.
  • Sound knowledge of sterile product testing, microbiological considerations, and environmental monitoring is an advantage.
  • Experience in leading audits, and technical troubleshooting in a sterile QC setup.
  • Effective communication and cross-functional collaboration

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