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
• Technical skills &
• Competencies / Language
• Analytical ability
• Trouble shootings
• Co ordination
• Communication
• Leadership
• Problem solving.
• Team building
• JOB PURPOSE
• Generic
• 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.

Benefits

Additional Information

JOB TITLE: Manager Quality Control, Pharmaceuticals

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