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Zentiva in Ankleshwar, Gujarat, India is seeking an Executive Quality Control professional to implement QC activities for Pharmaceuticals in accord with GMP, GLP and HSE guidelines, ensuring high-quality products that meet customer expectations.
The role involves testing and release planning for materials, raw materials, intermediates and finished goods, maintaining strict laboratory records, calibrations, and SOPs, and coordinating with production and warehouse teams to support timely analysis.
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.
Education / Experience
Post Graduate in Science (Organic Chemistry )
2-4 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.
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 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.
Preparing protocol for Analytical Method validation/Transfer, cleaning validation and performing the validation exercise as per the protocol.
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 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.