Job Title: Reviewer / Senior Reviewer
No. of Posts: 4
Salary: INR 60,000 – 3,00,000 P.A.
- 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 of Pride, Accountability, Integrity and Diligence.
- Perform additional duties as assigned by the Manager, related to the function.
Minimum 4-8 years of pharmaceutical experience.
Responsible for the following aspects of the Annual Product Review program;
o monitoring of execution of APQRs as per due dates
o 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.
- Date of Interview – 11th January
- Time of Interview – 10 AM onwards
- Venue of Interview -5th Floor, Block ‘A’, Building Godrej IT Park – 02 GBD,Godrej Business District, Pirojshanagar, Vikhroli, Mumbai