Deputy Manager, Quality Control

1 week ago

Dahej SIR Gujarat India Amneal Full time ₹ 12,00,000 - ₹ 36,00,000 per year
Description

Essential Functions

• Plan and supervise preventive maintenance, calibration, and verification of QC instruments.

• Ensure timely release of raw materials, intermediates, and packing materials as per approved specifications.

• Maintain strict compliance with GLP, safety protocols, and laboratory housekeeping.

• Prepare and review stability protocols, monitor sample charging/withdrawal, and approve stability reports.

• Investigate deviations, OOS, OOAL, and incidents; implement effective CAPA.

• Review and approve QC-related change controls, SOPs, and specifications.

• Conduct audit trail reviews and ensure electronic data integrity for software-enabled instruments.

• Oversee LIMS operations and ensure accurate documentation and traceability.

• Identify training needs and support skill development for QC personnel.

• Manage analytical column inventory and laboratory standards as per SOPs.

Additional Responsibilities

• Support internal/external audits and regulatory inspections.

• Drive continual improvement initiatives in QC processes and compliance.

• Perform any additional assignments allocated by QC Head/Designee.

Skills:

• GLP & GDP Compliance – Advanced

• Stability Study Management – Advanced

• Data Integrity & LIMS Operations – Advanced

• Deviation/OOS Investigation – Advanced

• Regulatory Compliance & Documentation – Advanced

• Leadership & People Development – Advanced

Other Skills:

  • Laboratory Data Management - Advanced
  • Stability Study Documentation - Advanced
  • Specifications & Test Methods Documentation - Advanced
  • Analytical Method Validation Documentation - Advanced
  • CAPA, Deviation, and Change Control Management - Advanced
  • Training and Compliance Record Management - Advanced
  • Knowledge of Regulatory guidelines/Requirement - Advanced
  • Analytical evaluation of vendor - Advanced
  • Method Validation/verification Protocol Design/review - Advanced
  • GMP Compliance for Environmental Monitoring - Advanced
  • Documentation & Data Integrity Practitioner - Advanced
  • CAPA, Deviation, and Change Control Management - Advanced
  • Specifications & Test Methods Documentation - Advanced

Specialized Knowledge: Licenses:

Qualifications

Qualifications
Education:

• M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.
Experience:

• 12+ years of experience in QC operations within API manufacturing.

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