Deputy Manager, Quality Control at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GLP & GDP Compliance, Stability Study Management, Data Integrity & LIMS Operations, Deviation/OOS Investigation, Regulatory Compliance & Documentation, Leadership & People Development, Laboratory Data Management, Stability Study Documentation, Specifications & Test Methods Documentation, Analytical Method Validation Documentation, CAPA, Deviation, and Change Control Management, Training and Compliance Record Management, Knowledge of Regulatory Guidelines/Requirement, Analytical Evaluation of Vendor, Method Validation/Verification Protocol Design/Review, GMP Compliance for Environmental Monitoring

Industry

Pharmaceutical Manufacturing

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:

Responsibilities

The Deputy Manager, Quality Control will plan and supervise preventive maintenance and ensure compliance with GLP and safety protocols. They will also investigate deviations and manage QC-related documentation and training.