OverviewOTC Contract Compliance Associate Full Time in Mississauga, ON
Branch Mississauga ON CA
Contract Compliance Associate
The Compliance Associate ensures compliance of the Canadian Operations and compliance of products sourced from Third Parties and Novartis Sites by supporting…
The Compliance Associate ensures compliance of the Canadian Operations and compliance of products sourced from Third Parties and Novartis Sites by supporting the implementation of quality modules and quality directives; supporting QA investigations; completing compliant investigations; supporting external and corporate audits; completing Annual Product Quality Reviews (APQRs); maintaining and ensuring compliance with all relevant regulatory and legislative requirements; ensuring compliance with Quality Agreements and executing Quality training as directed by Manager.
Manage the Canadian Complaints Handling processes, ensuring that all product quality complaints are being adequately investigated, trended, reported and ensure initiation of any follow-up activities to ensure compliance with the cGMP, Novartis Quality Manual, regulatory and legislative requirements. Ensure Global and Local SOPs relating to Technical Complaints are in place, as appropriate and trained. Execute timely completion of Canadian Annual Product Quality Reviews (APQR/PQR) in compliance with established schedules. Ensure initiation and tracking of any follow-up activities as they relate to product or process improvements. Ensure Global and Local SOPs relating to APQRs are in place, as appropriate and trained. Support the preparation for Health Authority inspections and audits and provide support to their execution and follow-up. Ensure that Corrective and Preventive Actions (CAPAs) are tracked and implemented as committed and ensure timely remediation of any issues related to CAPAs. Regularly report on the status of CAPAs. Support timely and complete product quality investigations related to Product Recall, Counterfeit and/or Withdrawals in close interaction with region, global and other country QA functions. Fulfil the requirements of the self-inspection program within Canadian Operations ensuring procedures, processes and records relating to Consumer Complaints and APQRs are reviewed for compliance with Canadian cGMP and Novartis Quality Modules, as appropriate. In partnership with Manager, ensure timely collection and reporting of defined Key Performance and Quality Indicators (KPIs and KQIs). Support quality awareness efforts within the Canadian organization and third party contractors. Eliminate barriers and proactively investigate quality issues using ap-propriate process improvement and problem solving techniques. Execute training as appropriate and directed by Manager. Support the maintenance of QAAs Provide backup to other QA staff, as required and directed by Manager.
• 3+ years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs. Experience in working collaboratively with Third Party organizations and internal stakeholders. Strong professional experience in cGMP, Quality Systems, analytical chemistry, manufacturing processes, packaging processes, and current industry practice. Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, PowerPoint, & Visio. Experience in working in a multidisciplinary environment.
Employment Type: Full Time
Location: Mississauga, ON, CA
Posted on: 2014-12-17