Manager Quality Control, Pharmaceuticals

REQUIREMENTS

Education / Experience

• M.Sc. or Higher Qualification in Analytical/Organic/Applied/ Pharmaceutical Chemistry.
• Min. 8-12 years’ experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment, with exposure to QC operations in Pharmaceutical/API manufacturing company

JOB PURPOSE

Generic

Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality guidelines 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 Ethics.

KEY ACCOUNTABILITIES

Testing and release

Planning of timely sampling and analysis and review of raw material, bulk product, intermediates, finished goods, packing material and other samples for Pharmaceuticals.

Performing analysis of Raw Material Samples received from new vendors for Pharmaceuticals.

Planning For analysis of market complaints, Stability, process validation samples and Cleaning Validation of Pharmaceuticals.

Approval / Rejection of Raw Materials, Packaging Components and in process material.

OOS/OOT/Deviation investigations

Review of analytical, chromatographic and computerized data for intermediates, and APIs for Chemistry Ankleshwar.

Timely completion of calibration and calibration of laboratory instrument

Support troubleshooting of QC instruments

LIMS management and support to QC operations

Good Laboratory Practice

Planning for calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.

Reviewing pharmacopeias for specification preparation.

Preparing SOPs and Formats and Analytical Test Record.

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

Reviewing and observing Retention Samples and maintaining record.

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

Maintaining & reviewing laboratory raw data related to testing activity.

Responsible for reviewing the chromatographic data.

Validation

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

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, QA, QMS and warehouse for analytical activities.

Other

Compliance to HSE Requirements for QC laboratory.

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 team members for laboratory related jobs and evaluate for individual development.