A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Associate Q.A. Manager - II
Job Description:
•Perform review of GMP relevant documents such as analytical raw data, analytical methods etc. for compliance with SOPs / Guidelines etc.
• Negotiate GMP deficiencies with Line Unit.
• Recognises complex deficiencies in the GMP documents and reports to the supervisor.
• Writes and complete GMP relevant documents in own area of responsibility.
• Participate in training and coaching the new employees of Line unit with respect to GMP aspects
• Assures Lifecycle of Equipment / Facility and Computerized Systems corresponds to requirements are appropriately implemented and followed. • Review Stability Study records, Protocols and Reports for Drug Substance and Drug Products.
• Approve Deviation management and Change control for premises/facilities and equipment, IT systems and Analytical Documentation.
• Carry out internal audits as well as vendor/supplier audits.
Candidate Profile:
Post graduate in Life Sciences / Chemistry / Biochemistry / Biochemical engineering. Fluent in English. Excellent verbal and written communication skill is essential.
Minimum 5 years in a GMP analytical laboratory with Excellent knowledge of cGMP requirements, with experience in the field of qualification of equipment / facilities and stability studies. with preferred 1/2 years experience in QA/ QC.Auditing experience if possible. Excellent english knowledge (oral and written). Ability to review / interpret data and draw appropriate conclusions. Effective team player, able to work in a flexible, dynamic working environment .Experience from MNC is preferred.
Additional Information:
Qualification:Post graduate in Life Sciences / Chemistry / Biochemistry / Biochemical engineering
Industry Type: Pharma/ Healthcare/ Clinical research
Location: Hyderabad
Functional Area: Quality
Job ID: 180918BR
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