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
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.
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.
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
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.