Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The Quality Assurance Analyst II will provide support to operations by providing oversight to activities associated with the manufacturing and packaging of bulk and finished products by Teva affiliates and third-party suppliers to ensure compliance with GMPs. Review and approve supplier documentation related to product release, validation, deviation, change controls, etc. Perform release of third-party products to market. Perform impact assessment with respect to the critical GMP issues. Conducting investigation related to deviation, OOS and OOT.
- Provide oversight of activities associated with the manufacture & packaging finished products by Teva affiliates and interact with EMSO QA who manages 3rd party suppliers to ensure compliance with GMPs.
- Review & approve GMP documentation associated with Teva affiliates and 3rd party supplied finished products including release documentation, deviations, validations, change controls, etc.
- Perform release of Teva affiliates and 3rd party products to market.
- Liaise with Teva affiliates suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues.
- Ensure compliant, on-time launches of Teva affiliates product in coordination with internal & external groups.
- Investigate Product Complaints and ensure the timely closure of the records in Harmony Track Wise.
- Perform comprehensive and detailed investigations for quality deviations (DR’s) in a timely manner. Perform impact assessment for third party products towards Critical Incident Notification / Alerts.
- Provide metrics to Teva Global / Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc; Generate / trend monthly and quarterly reports.
- Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner.
- Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.
- Perform Executed Batch Record Review for Teva affiliate products.
- Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly.
- Perform retain sampling activities: conduct the receipt of retain samples, updating of SAP / storage of retain samples and destruction of expired retain samples as per procedures.
- Support other Compliance functions and projects as required. Support inspections.
- Lead / Manage special projects that require collaboration with cross-functional teams and Teva Global Affiliates.
- Hazard Recognition and Investigation Skills: Identify, prevent, and proactively correct workplace hazards and conditions. Perform incident/accident investigations, root cause analysis, and establish appropriate corrective actions.
- Role Modeling: Role modelling of EHS practices to prevent the release of materials/energy, reduce EHS impacts, and ensure adherence to EHS regulatory requirements and procedures.
- Good working knowledge of SAP, LIMS, Track wise, Excel and Word.
- Thorough understanding of manufacturing, packaging and laboratory operations.
Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
Required: Three to four years relevant experience in Quality Control, Quality Assurance or Operations. Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods. Experience in Analytical method evaluation and investigation of OOS and OOT results.
Preferred: Six (6) years relevant experience in Quality Control, Quality Assurance or Operations or a proven track record within pharmaceutical industry.
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.