Assistant Manager Quality Control, Pharmaceuticals

Requirements

• Education / Experience
• Post Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm
• 5-7 years in chemical & instrumental testing laboratory with exposure to GMP, GLP
• Technical skills &
• Competencies / Language
• Analytical ability
• Trouble shootings
• Co ordination
• Communication
• Problem solving
• JOB PURPOSE
• Generic
• KEY ACCOUNTABILITIES
• Testing Performing and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.
• Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals.
• Good Laboratory Practice Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
• Reviewing pharmacopeias for specification preparation.
• Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
• Managing reference standards, working standards, Laboratory chemicals & reagents.
• Managing instrument laboratory with reference to spares, maintenance etc.
• Managing Control Samples and related record.
• Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device.
• Investigating out of specification results, retesting and review the analysis records.
• Maintaining & reviewing laboratory raw data and log book related to testing activity.
• Responsible for reviewing the chromatographic data.
• Validation Preparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol.
• Support testing of process validation/verification samples
• 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 operations
• 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 the subordinate for laboratory related jobs.

Benefits

Additional Information

JOB TITLE- Assistant Manager Quality Control, Pharmaceuticals

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Company Intel

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