Job Description:
Job Summary
Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported. Responsible to perform Stability data trending for investigations and for Annual Stability Summary Review packages for the APQRs to ensure compliance with established timelines and Good Manufacturing Practices. Provide required stability data to customers for their product compliance files.
Job Summary
Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported. Responsible to perform Stability data trending for investigations and for Annual Stability Summary Review packages for the APQRs to ensure compliance with established timelines and Good Manufacturing Practices. Provide required stability data to customers for their product compliance files.
Job Responsibilities
• Prepare, review and publish Stability Summary Reports within compliance time frame.
• 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.
• Perform shelf life extensions or reductions for product as required and as per approved procedures.
• Perform trend analysis as requested by the customers and 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.
• Interpret statistical analysis from NWA.
• Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Team Leader 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 Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex’s Health and Safety policies, and Safe Work Procedures.
• Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
• Initiate Change Control Records for shelf life extensions/reductions, SOP’s as necessary.
• All other duties as assigned.
• Prepare, review and publish Stability Summary Reports within compliance time frame.
• 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.
• Perform shelf life extensions or reductions for product as required and as per approved procedures.
• Perform trend analysis as requested by the customers and 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.
• Interpret statistical analysis from NWA.
• Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Team Leader 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 Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex’s Health and Safety policies, and Safe Work Procedures.
• Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
• Initiate Change Control Records for shelf life extensions/reductions, SOP’s as necessary.
• All other duties as assigned.
Additional Information
Experience : 4-10 years
Qualification : BSC. Degree or Diploma in a Life Sciences
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global QC Stability Data Analytics
End Date : 25th April, 2019
Experience : 4-10 years
Qualification : BSC. Degree or Diploma in a Life Sciences
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Global QC Stability Data Analytics
End Date : 25th April, 2019
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