The JAMP group is a proud Canadian owned company with its international headquarters located in Boucherville, 20 minutes from downtown Montreal, Quebec, Canada. The JAMP Pharma Group is active in all sectors of the pharmaceutical industry with our JAMP Pharma Generics, Orimed branded products, our Wampole and Laboratoire Suisse natural health supplements and our Cosmetic Import beauty and personal care products. The JAMP Pharma Group has also made a major investment in biosimilars which is one of the fastest growing markets in the pharmaceutical industry.
Post : Quality Assurance - Stability - Executive / Senior Executive
Key Responsibilities
• Review and keep all the documents related to the stability of the drugs (DIN) and natural health products (NHP) on file.
• Evaluate the change control requests and the impact on the stability of the products.
• Review the stability data of the products and issue recommendations for the shelf life Prepare the stability protocols and annual stability summary review for finished products (DIN and NHP).
• Review the stability results provided by the laboratories (certificates of analysis) against the product specification, investigate OOS results and write non-conformity reports.
• Quarterly follow-up on ongoing stability programs made by third parties.
• Keeps updated the schedule of all stability-related activities and the shelf-life information of the products.
• Provides support to other compliance areas such as SOP-related activities, training, APQR and EIRA assessment, recalls, and internal audits, if needed.
• Collaborates with the various activity sectors external to Quality Assurance such as the quality control analysis laboratory, product launch teams, business development, technology transfers and regulatory affairs as needed.
• Promotes Good Manufacturing Practices (GMP).
Department : Quality Assurance - Stability
Experience : 3 - 6 years
Location : Ahmedabad
Qualification : B.Pharma / M.Pharma / BSc / MSc
Send profile at sjani@jamppharma.com or Apply Online
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