Company Profile
Apotex
Research Pvt. Ltd.
Apotex Inc. was
founded in 1974, and is the largest Canadian-owned pharmaceutical company. From
its 2 employees, 5,000 square foot beginning, the company has grown to employ
over 10,000 people in research, development, manufacturing and distribution
facilities world-wide. The Canadian operations of the Apotex Group of Companies
has over 6,000 employees. Apotex produces more than 300 generic pharmaceuticals
in approximately 4,000 dosages and formats which, in Canada, are used to fill
over 89 million prescriptions a year - the largest amount of any pharmaceutical
company in this country. The company's pharmaceuticals can be found in
virtually every pharmacy and healthcare facility in Canada and are exported to
over 115 countries around the globe.
Time
and Venue
Walkin Interview on 11th January from 10 AM
onwards
5th Floor, Block 'A', Building Godrej IT Park -
02 GBD,Godrej Business District, Pirojshanagar, Vikhroli, Mumbai 400079 Time :
10:00AM - 3:00PM
Experience
& Skills:
Minimum 4-8 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.
Job
Responsibility:
-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.
