Quality Control Manager

Job Summary

Perform the Analytical activities as per the needs and as per the appropriate standard operating procedures in QC & AO department, Apotex Pharmachem India Pvt. Ltd.

Job Responsibilities

• Sampling of Raw Materials, Packing material, Intermediates and Finished Products.
• Execution of Method validation / Method transfer activity.
• Maintaining & monitoring of all the analytical method validation, cleaning validation and method transfer documents.
• Preparation and standardization of volumetric solutions.
• Calibration of all analytical instruments on need basis.
• Raw Materials, In-Process, packing materials, Intermediates, Finished Products and stability samples analysis on need basis.
• Performing Recertification of standards and impurities as required.
• Upkeep of laboratory cleanliness, ensuring compliance to good laboratory and safety practices.
• Coordination with other departments for smooth functioning of activities.
• Documentation of all works as required as per relevant Standard Operation Procedure (SOP).
• Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion.
• To adhere the EHS policy and procedure in routine activities
• All other duties as assigned

Job Requirements

• Education
  • Minimum M. Sc. in Chemistry
• Knowledge, Skills and Abilities
  • Demonstrated ability to solve and trouble shoot problems based on the analysis, experience and judgement.
  • Excellent understanding of business and supporting technology related to the Pharmaceutical industry. Excellent Knowledge and Experience with regulatory Compliance.
  • Strong motivational skills allowing to function independently as well as a proven ability to motivate others.
  • Knowledge on LIMS/ Trackwise / SAP. 

• Experience
  • Minimum of 7 years of experience in the area of Quality Control