Assistant Manager Quality Control, Pharmaceuticals

KEY ACCOUNTABILITIES

Performing and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.

Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals.

Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.

Reviewing pharmacopeias for specification preparation.

Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.

Managing reference standards, working standards, Laboratory chemicals & reagents.

Managing instrument laboratory with reference to spares, maintenance etc.

Managing Control Samples and related record.

Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device.

Investigating out of specification results, retesting and review the analysis records.

Maintaining & reviewing laboratory raw data and log book related to testing activity.

Responsible for reviewing the chromatographic data.

Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol.

Support testing of process validation/verification samples

Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.

Coordinating with production, and warehouse for analytical activities.

Compliance to HSE Requirements for QC operations

Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.

Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.   

Train the subordinate for laboratory related jobs.