Deputy Manager, Quality Control

12 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job 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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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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