Emcure is fast-growing Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally. With a presence in over 70 countries, Emcure's goal is to constantly innovate and deliver affordable & high-quality healthcare solutions to people.
Emcure looking for experienced professionals in QA department for our Injectable Unit, Sanand (Ahmedabad).
Post : AGM / DGM
Job Description :
• Should have detailed knowledge as well as experience of working for an injectable manufacturing (Aseptic/Terminal) process.
• Should have compendia and regulatory knowledge of aseptic processing and controls and Contamination control strategy program
• Expertise in facility/utility/equipment qualification and related guidance.
• Knowledge of software system for QMS, DMS and LIMS.
• Ensure compliance to the QMS E.g. Deviations, Change Control, CAPA, Market Complaint, Recall etc. and ensure timely closure of QMS activity.
• Lead the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training).
• Responsible for handling regulatory inspections, customer audit and to provide compliance and implementation of CAPA.
• To conduct Quality Risk Management and to monitor effectiveness of mitigation plan to reduce the risk
• To plan, monitor and ensure Process & Cleaning Validation / Verification
• Review, and approve drug product, labelled product executed batch records
• To review the procedure of Warehouse, Production, Engineering, QA & QC to meet the cGMP requirements
• Should have Experience of facing regulatory inspection USFDA and EU is must.
Expected to have good managerial and administrative skills and informative to support section head.
Additional Information
Qualification : M.Pharm./ B.Pharm./ M.Sc.
Experience : 16 to 22 years
Location : Sanand (Ahmedabad)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA department
End Date : 25th May 2024
Interested candidates may share their updated CV on mayur.desai@emcure.com with subject line “QA_Lead”
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