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 : Senior Executive Quality Assurance
Purpose of the position:
Perform a variety of routine and non-routine tasks in compliance with current good management procedures based on a strong knowledge of Stability procedures and systems. Writing and approving Stability protocols and reports, Analyzes and interprets Stability data, data trending and test results. Plans and prioritizes daily workload to ensure timely completion of projects and assignments. Contributes to the design of new Stability studies. Prepares quality stability reports and helps to prepare portions of regulatory submissions. Drawing up conclusions on shelf life/retest period and storage instructions, Leading Out-of-Specifications/Out-of-Trend investigations, Writing investigation reports, Determines next steps in compliance with applicable regulations; carries out technical and administrative duties as assigned. Conducts stability and analytical studies to solve moderately complex problems. Analyzes study results, and independently makes tactical decisions.
General Responsibilities:
- Be an advisor for stability related questions and issues
- Participate in projects as stability expert
- Follow-up / handle regulatory questions
- Manage changes of shelf life/retest period and storage instructions
- Build up scientific expertise and background knowledge on product behavior
- Be single point of contact within stability operations for the assigned product portfolio
Candidate Profile :
Experience Atleast 5 years and over 3 years with stability process in a GMP environment, knowledge of stability guidelines Bachelor of Pharmacy / Master of Pharmacy or M.Sc in Analytical Chemistry
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Technical Skills
Basic understanding of pharmaceutical formulations
Experience with analytical testing and deviation handling
Experience with IT document systems
Able to write and speak English fluently
Build strong knowledge base of stability behavior of products on stability
Experience of working in a regulated environment
Additional Information:
Experience: 5 years
Qualification: B.Pharm, M.Pharm, M.Sc
Location: Aurangabad
Job Function: QA
Requisition ID: 1600135824W
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