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Work as Associate Quality Manager in Novartis

 

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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 Quality Manager

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.
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:
Location: Hyderabad
Education:
M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Development & Medical
Division: pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
147285BR

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