Post : Sr. Reviewer/Reviewer-APQR
Job Description
• Monitoring of timelines for compilation, review & submission.
• Review of APQRs – ensuring raw data is complete, correct & reproducible.
• Identify system improvement opportunities for data gathering, template content/format, process efficiency.
• Expert knowledge of SAP transactions used to support the Product Review process.
• Provide technical support, feedback and guidance to team members to ensure the timely completion of APQRs.
• Acts as liaison between internal groups providing supplementary information and international affiliates.
• Communicate findings to the Manager / PLs and escalate any critical issues arising from the Product Review.
• Ensure timely communication of findings to the key business areas.
• Maintain the tracking system for compilation & review of assigned APQRs.
• Generate and provide monthly activity reports to the Manager.
• Create training materials and programs to support the Product Review process.
• Ensure that the annual product reviews are performed in full compliance with current procedures.
• Assist in the development & review of procedures as required.
• Detailed understanding of Apotex & Site SOPs / document and data systems supporting the Product Review process.
• Expert knowledge of International regulatory requirements that apply to Product Reviews.
• Provide support to Apotex during regulatory/customer audits related to APQRs.
• Respond to queries related to the Product Review systems.
• Support corporate and departmental compliance initiatives.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements & established safety standards.
• Work both independently & as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business & quality standards.
• Perform all work in support of the Corporate values
• Perform additional duties as assigned by the Manager, related to the function.
Candidate Profile
• Minimum Bachelor’s/Master Degree in Pharmacy or Master Degree in science
• Minimum 7-8 years of pharmaceutical experience.
• Responsible for the following aspects of the Annual Product Review program; monitoring of execution of APQRs as per due dates
• liaising with Project Leaders at Apotex
• Review of summary reports ensuring collected data is accurate & conclusions are appropriate.
• Accountable to ensure the compiled annual product reviews and supplementary reports are conducted in a timely manner as per established procedures.
• Responsible to escalate any critical issues arising from the Product Review.
• Acts as a technical resource and coach for the business units- internal and external stakeholders and affiliates in regards to the Annual Product Review quality system.
• Develop & mentor the APQR compilers to meet the compliance levels.
• Good oral/written communication, organizational and interpersonal skills.
• Minimum Bachelor’s/Master Degree in Pharmacy or Master Degree in science
• Minimum 7-8 years of pharmaceutical experience.
• Responsible for the following aspects of the Annual Product Review program; monitoring of execution of APQRs as per due dates
• liaising with Project Leaders at Apotex
• Review of summary reports ensuring collected data is accurate & conclusions are appropriate.
• Accountable to ensure the compiled annual product reviews and supplementary reports are conducted in a timely manner as per established procedures.
• Responsible to escalate any critical issues arising from the Product Review.
• Acts as a technical resource and coach for the business units- internal and external stakeholders and affiliates in regards to the Annual Product Review quality system.
• Develop & mentor the APQR compilers to meet the compliance levels.
• Good oral/written communication, organizational and interpersonal skills.
Additional Information
Experience : 7-8 years
Qualification : M.Sc. / M. Pharm / B.Sc / B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : APQR
End Date : 30th January, 2019
Experience : 7-8 years
Qualification : M.Sc. / M. Pharm / B.Sc / B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : APQR
End Date : 30th January, 2019
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