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.
Job Title: Associate, GBS – Global QC Stability Data Analytics
No. of Posts: 1
Job Description:
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 :
1. Prepare, review and publish Stability Summary Reports within compliance
time frame.2. Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
3. Review Stability data from third party affiliates for compliance.
4. Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
5. Perform shelf life extensions or reductions for product as required and as per approved procedures.
6. Perform trend analysis as requested by the customers and as per approved procedures.
7. 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.
8. Interpret statistical analysis from NWA.
9. 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.
10. Works as an effective team member to meet department goals, sharing knowledge with team members.
11. 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 Apotexs Health and Safety policies, and Safe Work Procedures.
12. Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
13. Initiate Change Control Records for shelf life extensions/reductions, SOPs as necessary.
14. All other duties as assigned.
Qualifications:
- BSc,MSc,B Pharm, M Pharm.
- Experience:- 3 Years to 7 Years.
- Excellent oral and written English communication skills.
- Demonstrated knowledge of Stability requirements.
- Self-starter, good interpersonal skills and results oriented team player.
- Ability to manage multiple priorities in a fast paced environment.
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Education:UG -B.Sc – Any Specialization, Bio-Chemistry, Botany, Chemistry, Diploma – Any SpecializationPG – MS/M.Sc(Science) – Any Specialization
