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: Stability Integrator/Owner
Job Description
The Stability Integration Specialist will:
* Be responsible for Stability Management of Drug Substance/Drug Products and site-to-site Analytical Method Transfers within JSC.
* Handle Stability and Analytical Transfer Management of a portfolio of products
* Be the first point of contact for stability and transfer related issues and lead for escalating stability OOT/OOS (out of tolerance/out of scope).
* Trend and profile product behavior.
* Support and coordinate investigations.
* Perform Scientific and Quality evaluation of generated results.
* Draw up conclusions on shelf life/ retest period, storage conditions and instructions, shipment excursions and method transfer status.
* Assure resources are planned (e.g., stability storage conditions and space, equipment, reagents, people, skills, etc.).
* Coordinate Safety Health & Environmental (SHE) assessments of new chemicals and reagents for the stability testing labs.
* Assess readiness of the stability group for New Product Introductions (NPI).
* Participate in projects as stability expert.
* Ensure compliance with all relevant regulations, guidance, compendial requirements for stability studies, analytical methods and specification.
Qualifications
1) A minimum of a Bachelor’s degree or equivalent degree is required
2) A degree focused in Science, Pharmacy or Industrial Engineering is preferred
3) A minimum of 4 years of relevant experience is required
4) Strong knowledge of related domestic and international Stability guidelines for the
5) Pharmaceutical/OTC business is required
6) Experience facilitating or contributing to method transfers is required
7) Advanced computer skills and experience with MS software applications (Word & Excel) are require
8) Experience with Minitab, LIMS and Trackwise are preferred
9) Good knowledge of statistical data analysis is required Project management experience and related certifications (PMP, FPx, etc.) are preferred
10) Experience working in a large enterprise, global environment is preferred.
11) This position will be based in Raritan, NJ, Titusville, NJ, Beerse, BE, Guaynabo, PR, or Higi, India and may require up to 5% travel.
Additional Information:
Experience: 4 years
Qualification: B.Sc/B.Pharm
Location: Maharashtra-Greater Mumbai
Job Function: Quality (Generalist)
Requisition ID: 0000155S
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