Assistant Manager Quality Control, Pharmaceuticals

JOB TITLE- Assistant Manager Quality Control, Pharmaceuticals

REQUIREMENTS

Education / Experience

Post Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm

8-10 years in chemical & instrumental testing laboratory with exposure to GMP, GLP

Technical skills &

Competencies / Language

• •Analytical ability
• •Trouble shootings
• •Co ordination
• •Communication
• •Problem solving

JOB PURPOSE

Generic

Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics.

KEY ACCOUNTABILITIES

Testing 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.

Good Laboratory Practice 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.

Validation 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

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

Co ordination Coordinating with production, and warehouse for analytical activities.

Other 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.