Manager - Quality Assurance - Pharma Sector

Emprise HR is a leading Executive Search having a strong presence in Pharmaceutical Sector scouting for Quality Assurance - Manager.

Experience : 10+ years

Position Description:

To ensure that the Products provided to the market are tested as per customer specifications and in compliance with applicable pharmacopoeias as well as cGMP/GLP/ICH/USFDA /ISO guidelines.

Key Responsibilities:

- Printing and preparation of record of analysis, labels (Inner & outer).

- Preparation of analytical specifications, method of analysis.

- Data punching in SAP and usage decisions.

- Log books management for various activities.

- To ensure that sampling of all Finished products is done as per defined procedure and proper record is being kept compliance to cGMP practice.

- Generation of notification and purchase request in SAP.

- Outsource testing of intermediate and finish products.

- To ensure good housekeeping in the working area as well as in surroundings.

- To ensure compliance to all SHE guidelines and to ensure safe working.

- Conducting monthly safety audit and ensuring the closures of observations.

- Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work .

- Clearance of safety work permits to ensure execution of activities in safe manner.

- To release the Batches of Intermediates and Finish goods in SAP.

- Stopping an Unsafe Act in own area.

Background & Experience:

- Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines, Working knowledge of Method development and validation.

Key user role - SAP.

- Minimum 4 years of experience in the Pharmaceutical industry and extensive Quality Assurance.

Requesting you to share the suitable profiles ASAP.

Nishtha