Apotex Inc.,
Designation : Senior Analyst
Reporting To : Asst.Manager
Function : Global Quality And Compliance
Functional Area : Stability Reviews
Job Role Summary : Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported. Provide required stability data to customers for their product compliance files
Job Profile :
- Prepare Stability Summary Reports within compliance time frame.
- To ensure summary reports are correct and complete as per Apotex procedures.
- Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
- Review Stability data from third party affiliates for compliance.
- Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
- Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
- Provide Annual Stability Review contribution packages to QA Product Review group for the Annual
- Product Quality Review (APQR). Notify Assistant Manager of any adverse trends detected.
- Works as an effective team member to meet department goals, sharing knowledge with team members.
- Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good
Job Requirements :
- Have good understanding of pharmaceutical Quality Control systems.
- Demonstrated knowledge of Stability requirements.
- Good interpersonal skills and results oriented team player.
- Able to work with minimum supervision.
- Communicate findings to the Assistant Manager, an escalate any critical issues arising from the Stability summary report.
Type of Experience : Regulated Pharma QA, Product Quality Review, Stability Management, QMS
Academic Qualifications :
- Master’s Degree in Science / Pharmacy
