Job Description
Key Deliverables of this role
• Experience in analytical testing of stability samples (drug products and drug substances), release testing.
• Preferably having knowledge on method transfer activities
• Having experience in handling and calibration of instruments like Dissolution tester, LC, GC
• Knowledge of Regulatory guidelines on stability like ICH guidelines.
• Peer data review in a compliant way.
• In dept knowledge on GMP/ safety requirements related to the lab activities.
• Planning of analytical projects based on priorities and established timelines
• Leading a group of people
• Handling of Quality records like Events/CAPA/COC etc
• Deliver the projects as per the agreed timelines
• Experience in analytical testing of stability samples (drug products and drug substances), release testing.
• Preferably having knowledge on method transfer activities
• Having experience in handling and calibration of instruments like Dissolution tester, LC, GC
• Knowledge of Regulatory guidelines on stability like ICH guidelines.
• Peer data review in a compliant way.
• In dept knowledge on GMP/ safety requirements related to the lab activities.
• Planning of analytical projects based on priorities and established timelines
• Leading a group of people
• Handling of Quality records like Events/CAPA/COC etc
• Deliver the projects as per the agreed timelines
Must have functional competencies
• Experience on troubleshooting the issues come across during the testing on Instruments and Equipment’s (like LC, GC, Dissolution tester etc.)
• Must be able to draw interpretation out of the stability data and trending
• Experience in writing the methods & stability protocol, reports. Reviewing the data of the reports for correctness.
• Review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, LIMS entries, etc
• Exposure to empower software for data processing preferred.
• Experience of working in a regulated environment is mustCandidate Profile
• Experience on troubleshooting the issues come across during the testing on Instruments and Equipment’s (like LC, GC, Dissolution tester etc.)
• Must be able to draw interpretation out of the stability data and trending
• Experience in writing the methods & stability protocol, reports. Reviewing the data of the reports for correctness.
• Review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, LIMS entries, etc
• Exposure to empower software for data processing preferred.
• Experience of working in a regulated environment is mustCandidate Profile
M.SC Chemistry or M.Pharm or Ph.D or equivalent At least 12 years in reputed pharmaceutical company. Exposure on Instruments like LC, GC, Disso for drug products, drug substances analysis.
Additional Information
Experience : 12 years
Qualification : M.SC Chemistry or M.Pharm or Ph.D
Location : Maharashtra-Greater Mumbai
Industry Type : Pharma
Functional Area : R&D
End Date : 25th October, 2018
Experience : 12 years
Qualification : M.SC Chemistry or M.Pharm or Ph.D
Location : Maharashtra-Greater Mumbai
Industry Type : Pharma
Functional Area : R&D
End Date : 25th October, 2018
No comments:
Post a Comment