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Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.

Post : Assistant Manager QA

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Job Description

  • Knowledge of Calibration of Instruments and Equipment
  • Awareness of the technological developments under stability management
  • Oversee the entire end to end Stability sample management process & Knowledge of reconciliation and destruction of stability samples as per regulatory requirement
  • Exposure to LIMS for handling of samples for stability, release etc. is preferred
  • Exposure to global stability management process
  • Knowledge on stability chamber qualification process
  • Well versed with 21CFR Part 11 and other global laboratory compliances requirements
  • Knowledge of statistical analysis of analytical data related to quality control of pharmaceutical products is preferred
  • Be an advisor for stability related questions and issues
  • Participate in projects as stability expert
  • Manage changes of shelf life/retest period and storage instructions
  • Build up scientific expertise and background knowledge on product behavior
  • Leads the group as SME in Internal/External audit process
  • Prepares relevant SOPs
  • Be single point of contact within stability operations

 

Candidate Profile
At least 6-8  years in reputed pharmaceutical company, in QC stability function with proven Leadership/Scientific skills Bachelors/ Masters’ degree in Science/ Pharmaceuticals
- Experience (over 6 years) with stability process in a GMP environment, knowledge of stability guidelines
- Basic understanding of pharmaceutical formulations
- Experience with analytical testing and deviation handling
- Experience with IT document systems
- Experience of working in a regulated environment
- Able to write and speak English fluently
- Build strong knowledge base of stability behavior of products on stability

Additional Information:
Experience:-
2-5 years
Qualification: M.Sc, B Pharm, M.Pharm
Location: Aurangabad, India
Department: Pharma
Job Function: Quality Assurance
Requisition ID: 1700166866W

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