Job Description
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .
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.
- Prepare Stability Summary Reports within compliance time frame.
- To ensure summary reports are correct and complete as per Apotex procedures.
- 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 software.
- Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Assistant Manager 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 Apotexs 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.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
Knowledge, Skills And Abilities
- Must have Good understanding of pharmaceutical Quality Control systems.
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- Strong data analysis & decision-making skills.
- Demonstrated knowledge of Stability requirements.
- Self-starter, good interpersonal skills and results oriented team player.
- Strong organisational, time management skills and able to work with minimum supervision.
- Communicate findings to the Assistant Manager, an escalate any critical issues arising from the Stability summary report.
- Possess the ability to manage multiple tasks and work independently in ambiguous situations.
- Work both independently and as part on intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
- Good understanding of cGMP regulations & experience with international regulations
- (e.g. FDA, EU) an asset.
- Excellent written and verbal communication skills.
- Experience with Microsoft Office applications. SAP, LIMS, TrackWise an added advantage.
- Minimum 4-8 years in the pharmaceutical industry with an emphasis on Quality Control & analytical data interpretation.
At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
Skills
Data AnalysisData InterpretationQuality ControlData AnalyticsAnalyticsIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
About Company
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 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. 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. Today, Apotex is a necessary and trusted member of Canada's healthcare community. 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. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value. Although the company's own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use. The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.
Important dates & deadlines?
Application Deadline
13 Jul 26, 05:42 PM IST
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Executive - GQC Stability Data Analytics
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