• Position : Senior Associate, Quality Assurance (Compliance) (Contract - Sun Pharma Canada)
  • Department : Quality Assurance (QA)
  • Requisition :21-Sun-QA2
  • Job Type : Full Time
  • Posting Date : 07/13/2021
  • Location : Brampton, Ontario

What we offer:    

  • A safe and clean; GMP regulated work environment
  • Opportunities for career growth and development
  • A competitive wage/salary
  • Incentive bonus programs that are designed to reward employees for their individual contributions
  • Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
  • Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

Sun Pharma Canada - Our Brampton location is presently looking for a Senior Associate, Quality Assurance (Compliance) (Contract - Sun Pharma Canada) to join our team.

General Summary:

The Sr. Associate, Quality Assurance (Compliance) is responsible for 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 supporting the processes associated with electronic systems used by Sun Pharma Canada Inc. organization. The Sr. Associate, Quality Assurance (Compliance) is also responsible for execution of all CAPAs associated with Health Canada inspections, internal audit and self-inspection program ensuring their timely closure and effectiveness check.

Principal Duties and Responsibilities :

  • Execute Annual Product Quality Review Program:
    • Monitor and execute tracking management strategy for APQRs
    • Communicate with Sun Pharma sites and CMOs and ensure APR receipt as per the schedule
    • Perform analysis of the APR information provided, add post-release product data and, issue APQR Executive Summary
    • Identify risks and work with Sun Pharma sites and CMOs on the corrective actions
    • Provide APR information to Sun Pharma Canada Inc. customers, as required
    • Maintain site SOP on this subject, as required.
  • Execute and Support Product Stability Program:
    • Monitor and maintain stability data tracking system
    • Ensure timely receipt of the stability reports and manage their data-base
    • Review Stability Reports and address with the manufacturer identified risks
    • Maintain site SOP on this subject, as required.
  • Quality Assurance Agreements (QAgs)
    • Monitor and maintain the list of all required QAgs with manufacturing and packaging facilities, testing laboratories, applicable vendors and distributor’s warehouse operations (list may not be all inclusive)
    • Establish QAg tracking system to ensure timely review, revision and approval
    • Connect and negotiate with the parties involved into the QAg development, review, enhancement and approval process
    • Affiliate with Sun Pharma Legal department on review and requirements of the QAg to ensure appropriate language in the documents
    • Maintain site SOP on this subject, as required.
  • Local Vendor Audit and Self-Inspection Program
    • Support development and maintain Annual Audit and Self-Inspection Plan and obtain approval of the Associate Director, Quality Assurance
    • For SPCI third party vendors, obtain confirmation and maintain records of audits performed by Corporate Quality Audit group.
    • Maintain site SOP on this subject, as required.
  • Global Documentation Implementation
    • Review the list of the Global Quality Standards and SOPs and identify the list for implementation
    • Monitor gap assessment process and ensure completion of all implementation associated activities
    • Provide all completed forms for review and approval as per the established process
  • Change Control Program Management
    • Ensure review and approval of the change control records and their appropriate content, risk-based impact assessment and associated actions
    • Ensure appropriate training of personnel and access in global QMS Trackwise
    • Maintain site SOP on this subject, as required.
  • Corrective Action and Preventive Action (CAPA) Program
    • Report and maintain Quality and Compliance metrics
    • Support 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
  • Sun Pharma Canada Inc. (SPCI) Training Program Management
    • Support training needs assessment process and identify training gaps
    • Report and maintain training metrics
    • Support implementation of the Corporate Quality training courses and annual GMP training program as per the training needs assessment
    • Maintain annual training calendar and attend GMP forum meetings on behalf of the department
    • Act as a Single Point of Contact (SPOC) for Sun Pharma Global Certification Programs and support their successful execution and effectiveness
    • Maintain site SOP on this subject, as required.
  • Sun Pharma Canada Inc. (SPCI) Product Quality Complaints Management
    • SPCI PQC Complaint Coordinator role according to established SOP.
    • Receive, initiate PQCs in complaint management system (i.e. TrackWise) and send the PQC to drug product manufacturing site for investigation.
    • Ensure that the PV local reference number or equivalent is appended to the PQC associated with ADE or lack of efficacy (LOE) complaint with product authorized (registered) for SPCI and its affiliate companies being referenced in the product complaint file for complaints received from the Canadian market.
    • Ensure PQCs associated with ADRs/lack of efficacy are communicated to Pharmacovigilance office.
    • Responsible for reconciliation of open cases (PQCs and ADRs) in quality database.
    • Enter all information received from complainant / pharmacy (samples, letters, etc.) in complaint management system.
    • Follow up with complainant for missing information and complaint sample procurement. Enter information received into complaint management system.
    • Provide investigation response letter to complainant, if requested.
  • Additional duties as assigned

Knowledge, Skills and Abilities

·        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

·        Excellent communication skills (written and oral) including presentation skills, technical writing, organization and negotiation skills

·        Compliance Programs/Project management experience is an asset

·        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

If you are interested in this opportunity, please submit your resume to hr@taro.ca referencing Senior Associate, Quality Assurance (Compliance) (Sun Pharma Canada) in the subject line. We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

To learn more about Taro Pharmaceuticals Inc., please visit: www.taro.ca.

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