Executive - Quality Control

JOB TITLE

Executive Quality Control, Pharmaceuticals

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 .

REQUIREMENTS

Education / Experience

Post Graduate in Science (Organic Chemistry )

2-4 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.

Technical skills &

Competencies / Language

- Analytical ability

- Trouble shootings

- Co ordination

- Communication

- Leadership

KEY ACCOUNTABILITIES

Testing and release

P lanning 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.

Good Laboratory Practice

P lanning 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.

Reviewi ng 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 .

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, and warehouse for analytical activities.

Other

Compli ance 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.
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