• Position : Manager, Quality Assurance and Compliance
  • Department : Quality Assurance
  • Requisition :
  • Job Type : Contract
  • Posting Date : 03/13/2019
  • Location : Brampton, Ontario

Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

Our Brampton location is presently looking for a Manager, Quality Assurance and Compliance to join our Sun Pharma Quality Assurance Department for a 6 month contract.

The Manager, Quality Assurance and Compliance is responsible for management and execution of all compliance Programs for Sun Pharma Canada Inc. as per Health Canada requirements.  Also the individual in this role is responsible for management of the processes associated with electronic systems used by Sun Pharma Canada Inc. organization. The Manager, Quality Assurance and 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 :

Manage Annual Product Review Program:

  • Develop and execute tracking management strategy
  • Communicate with Sun Pharma sites and CMOs and ensure APR receipt as per the schedule
  • Perform analysis of the provided information and add post-release product data, issue APR Executive Summary
  • Identify risks and work with the product manufacturers on the corrective actions
  • Develop and maintain site SOP on this subject

 

Develop and maintain Quality Assurance Agreements

  • Develop and maintain the list of all required Quality Assurance Agreements with manufacturing and packaging facilities, testing laboratories, applicable vendors and distributor’s warehouse operations
  • Establish QAA tracking system to ensure their timely revision and approval
  • Connect and negotiate with the parties involved into the QAA review and approval process
  • Affiliate with Sun Pharma Legal department on review and requirements of the QAA to ensure appropriate language in the documents
  • Develop and maintain site SOP on this subject

 

Responsible for Global Documentation Implementation

  • Review the list of the global Quality Standards and SOPs and identify the list for implementation
  • Manage 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 personnel training in global QMS Trackwise

 

Corrective Action and Preventive Action (CAPA) Program

  • Develop and maintain Quality and Compliance metrics
  • Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process
  • Own and execute CAPAs associated with Health Canada, Internal Audit and Self-Inspection observations

Local Vendor Audit and Self-Inspection Program

  • Develop Annual Audit and Self-Inspection Plan and obtain approval of the Associate Director, Quality Assurance
  • Assign audits to the certified Sun Pharma Canada Inc. employees based on their certification, experience and expertise
  • Develop and maintain site SOP on this subject

 

Knowledge, Skills and Abilities

Background and Experience Required:

  • Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada standards 
  • Minimum 7+ 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
  • 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 Manager, Quality Assurance and Compliance 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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