Manager, Quality Assurance & Compliance

Job purpose

The Senior Associate, Quality Assurance (Compliance) is responsible for the execution of key compliance Programs in Sun Pharma Canada Inc. as per Health Canada requirements.  In addition, the individual in this role is responsible for performing processes associated with electronic systems used by Sun Pharma Canada Inc. organization.

Duties and responsibilities

• Execute Annual Quality Product Review (APQR) / Yearly Biologic Product Review (YBPR) Program:
  • Prepare APQRs / YBPR as per approved annual schedule.
  • Communicate with Sun Pharma sites and CMOs and ensure Annual Product Review (APR) / Product Quality Review (PQR) receipt as per the schedule
  • Perform analysis of the provided information and add post-release product data, issue AQPR Executive Summary
  • Submit YBPR to SPCI Regulatory Affairs for submission to Health Canada as per annual schedule
  • Identify risks and work with the product manufacturers on the corrective actions
  • Provide AQPR information to Sun Pharma Canada Inc. customers, as required
  • Maintain site SOP on this subject, as required.

• Responsible for Global Documentation Implementation and Site SOPs
  • Perform gap assessment process as per  list of the SUN Global Quality Standards (GQSs)and Global SOPs (GSOPs) and ensure completion of assigned implementation related activities
  • Provide all completed forms for review and approval as per the established process
  • Draft site SOP(s), as required and assigned
  • Revise site SOPs and related documents, as assigned (e.g. adhoc revisions and periodic reviews)

• Sun Pharma Canada Inc. (SPCI) Electronic Document Management System (EDMS)
  • Perform role of EDMS Site Coordinator, as assigned.
  • Perform workflows as per GSOP000160 Document Management in Electronic Document Management System (EDMS - 21.2).

• QMS TrackWise System
  • Perform role of TrackWise Coordinator, as assigned.
  • Perform workflow for User Access Management records in TrackWise.
  • Communicate system related information to end users.
  • Provide workflow trouble shooting support to end users, as required.

• Change Control Program Management
  • Review and approval of assigned change control records and ensure their appropriate content, risk-based impact assessment and associated actions
  • Maintain site SOP on this subject, as required.

• Corrective Action and Preventive Action (CAPA) Program
  • Maintain Quality and Compliance metrics, as assigned
  • Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process
  • Execute CAPAs associated with Health Canada, Internal Audit and Self-Inspection observations, as assigned

• Sun Pharma Canada Inc. (SPCI) Learning Management System (LMS)
  • Perform role of LMS Local Training Coordinator (LTC), as assigned.
  • Perform workflows as per GSOP000063 Management of Training Activities in Learning Management System (LMS).

• Sun Pharma Canada Inc. (SPCI) Training Program Management
  • Develop, report and maintain training metrics
  • Prepare and maintain annual Integrated Training Calendar (ITC)
  • Maintain site SOP on this subject, as required.

• Product Release
  • Request and maintain supplier master documents for products released in Canada.
  • Perform incoming product inspection, download temperature data and review incoming product receiving documents.
  • Perform collaborative review of incoming product for release to Canadian market for support to Supply Chain.
  • Co-ordinate warehouse QA activities for incoming inspection and release based on determined priorities.
  • Interact with suppliers for receipt of release documents and supporting issues.
  • Review supplier batch documents (CoA, CoM, CCR, OOS/deviation where applicable and relevant batch Records) and support product release in Canada as per applicable Health Canada requirements.
  • Manage final disposition within SAP.

• Executed Batch Record (EBR) Review
  • Request executed batch records from manufacturing site as assigned.
  • Perform Executed Batch Record (EBR) review as assigned
  • Interact with manufacturing site to resolve queries identified during EBR review.

• Additional duties as assigned

Additional responsibility (Only applicable to customer facing roles)

• Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Background and Experience
  • Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada standards 
  • Minimum 5+ years of experience in Quality Assurance department working under Health Canada GMP regulations
  • Experience in dealing directly with Regulatory Agency officials (Health Canada)
• Knowledge, Skills and Abilities:
  • Excellent communication skills (written and oral) including presentation skills, technical writing, organization and negotiation skills
  • Compliance Programs/Project management experience
  • Proven problem solving ability with evidence of good judgment and decision making skill
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines 
  • Excellent working knowledge of GMP and regulatory requirements for the pharmaceutical industry
  • Strong proficiency with applicable computer software

Working conditions

General office based conditions

Physical requirements

Hybrid model - 3 days in office and 2 days work from home

Direct reports

NA