Opportunity for M.Pharm, M.Sc, B.Pharm as Quality Operations Executive at Merck Limited
Our businesses in U.S. and Canada operate as EMD Serono in Biopharma, MilliporeSigma in life science and EMD Performance Materials in the chemicals and high-tech materials business. Outside of the U.S. and Canada, we hold the rights to the name and the trademark “MERCK”. The businesses of Merck KGaA, Darmstadt, Germany are truly global, with 52,000 employees in 66 countries working on breakthrough solutions and technology.
Post : Executive-Quality Operations
1. Monitoring of manufacturing & packing activity as per Product Compliance File (PCF) at Contract Manufacturing Organization (CMO).
2. Reporting of discrepancies and non-compliance observed during Manufacturing, Packaging and Action taken at CMO.
3. Implementation of corrective and preventive action for non-conformances observed during manufacturing.
4. Review of Batch Manufacturing Record & Batch Packing Record prior to dispatch of the batch from CMO and reporting the non-compliances to site management for CAPA actions with an information to Quality Opearations (QO), Merck.
5. To observe critically all operation as per directive given in Product Compliance File.
6. To issue written memo/mail to concern Department Manager for corrective action and after satisfactory compliance allow to start activity.
7. To ensure that the batch manufacturing & packing records prepared & used by CMOs are in-line with the Master Formula Records issued by Merck QO.
8. Highlighting the gaps for corrective & preventive actions on the same for closing the identified gaps in consultation with QO, Merck.
9. Performing the independent investigation for complaints and/or deviation whenever applicable and submitting the report to QO, Merck.
10. Support in technology transfer of identified products at CMO with required system and procedure, including documentation.
11. Imparting training to concerned stake holders
Roles & responsibilities:
• Liasoning with different stake holders in Merck head Office.
• Liasoning with different stake holders at CMO
• Interaction with senior management / Leadership team at CMO
• Graduate/Post graduate in Science or Pharmacy
• Minimum 6 years experience in Pharmaceutical Industry
• Must have worked in Quality Assurance in a pharmaceutical of repute
• Effective communication skill (written & verbal)
Experience : 6 years
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Location : Maharashtra
Industry Type : Pharma
Functional Area : Quality Operations
End Date : 25th August, 2018
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