Work as Assistant Manager in Quality Assurance at Johnson & Johnson

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

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