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May
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ragupathyrenganathan
Required! Quality Assurance Associate – Investigations
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QA Associate – Investigations

Regular, Full-time Opportunity

At Teva Canada, we believe that all Canadians deserve access to innovative and affordable medications. We develop, produce and market generic pharmaceuticals, from diabetic agents to antibiotics, from heart medications to cancer treatments. We’ve been part of Canadian healthcare since 1965, when we began operations as one of the country’s first generic pharmaceutical companies. Today, we employ over 1,500 Canadians. We invest in facilities in this country—creating generic and brand-name medications. And we’re proud to be part of Teva Pharmaceutical Industries Ltd. Worldwide, Teva is the leader in generics, one of the top 10 pharmaceutical companies, active in 60 countries and a workplace of choice for 46,000 dedicated employees.

We are motivated by a passion to make a difference.

tevamakesmedicines.ca | tevacanada.com | tevacanadainnovation.com | tevapharm.com

Responsibilities
  • Perform comprehensive and detailed investigations relating to manufacturing/packaging, Complaints, OOS Calibrations and analytical failures to ensure compliance with GMP, GDP and Teva Canada SOP
  • Perform investigations for potential Field Alerts
  • Prepare and issue Global Notification to Management impact assessments, responses and critical incidences
  • Create/issue QA protocols for sampling and/or inspections and lead AQL evaluations.
  • Work collaboratively with site operations/QA in the resolution of GDP/GMP deviations
  • Liaise with Planning, Operations, Validation, Technical Operations, QC, Regulatory Affairs, Compliance, other QA teams, Manufacturers, Suppliers, Customers, to obtain necessary information/documentation required for product review/release/investigations to meet MPS schedule
  • Provide clear QA guidance
  • Work with various operational departments to negotiate, follow up and facilitate the completion of CAPAs and CAPAER
  • Review & approve calibration out-of-specification investigations including providing impact assessments
  • Review and release of finished products
  • Perform timely reviews and approvals of non-routine GMP Work Orders and Engineering Change Controls (ECR) ensuring appropriate steps/actions have been taken and impact assessment is documented
  • Review, process and approve Material Item Transfers (MITRs)
  • Manage Oracle lot status (Hold / off Hold) as per DR disposition
  • Act as the back-up for Supervisor in:meeting attendance, decision making, issue resolution, coordination of work assignment and work reporting, drive for timely completion of investigations and implementation of CAPAs for self and team
  • Review  and provide  feedback on investigations and procedures for team members,
  • Review and approve IQ/OQ protocols, TS and Validation protocols
  • Perform other duties as assigned
Qualifications

To  be successful in this position you will have effective communication skills both oral and written. Using your communication skills, you can relay complex information and influence others to your point of view.

You enjoy leading projects and can manage and prioritize multiple projects using your proven time management skills.

You use your analytical skills to resolve problems, conflicts and issues.

You have demonstrated the ability to coach and provide feedback on investigations to more junior team members.

You will also have:

  • University Degree in a Science or related discipline
  • Requires a mechanical aptitude to understand manufacturing and packaging operations as well as the mechanical aspects of the plant such as HVAC and Purified Water systems
  • Experience with statistical analyses
  • Strong knowledge of Packaging, Manufacturing and Laboratory processes in a Pharmaceutical environment
  • Working knowledge of GMP regulations and other Regulatory requirements for Canadian and US markets
  • Technical expertise working with Oracle, Knowledge Tree, LIMS, MS Windows XP/2000 MS Office, Statistical software (such as Minitab, StatGraphics, WinSPC or Excel)

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