Officer Control, Pharmaceuticals

3 days ago

Ankleshwar, India Zentiva Group, a.s. Full time

Education / Experience

Post Graduate in Science (Organic or Analytical Chemistry )
- 0-2 years in chemical & instrumental testing laboratory with exposure to GMP, GLP.
- Testing- Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.- Performing analysis of Raw Material Samples received from new vendors for Pharmaceuticals.- Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals.- Good Laboratory Practice- Performing 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.- Arranging and observing Control Samples and maintaining record.- Participating in Investigation of 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, 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, spares, 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.

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