Position : Manager, QA (Compliance)
Department : Quality Assurance, Sun Pharma Canada Inc.
Requisition : 20HRCN-QA-Manager-Sun-Canada
Job Type : Full Time
Posting Date : 06 / 15 / 2020
Location : Brampton, Ontario
Sun Pharma Canada Inc. - Our Brampton location is presently looking for an Manager, QA (Compliance) -12 month contract to join our Quality Assurance, Sun Pharma Canada Inc. Department.
General Summary :
The Manager, Quality Assurance (Compliance) is responsible for management and 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 managing the processes associated with electronic systems used by Sun Pharma Canada Inc.
organization. The Manager, Quality Assurance (Compliance) is also responsible for management and execution of all CAPAs associated with Health Canada inspections, internal audit and self-inspection program ensuring their timely closure and effectiveness check.
This role provides support regarding communications with Health Canada and regulatory / customer / internal audits management.
This role provides support regarding communications with Health Canada as well as regulatory / customer / internal audits management.
Principal Duties and Responsibilities :
Manage and Execute Annual Product Review Program : Develop, monitor and execute tracking management strategy for APQRsCommunicate with Sun Pharma sites and CMOs and ensure APR receipt as per the schedulePerform analysis of the provided information and add post-release product data, issue APR Executive SummaryIdentify risks and work with the product manufacturers on the corrective actionsProvide APR information to Sun Pharma Canada Inc.
customers, as requiredMaintain site SOP on this subject, as required.
Manage and Execute Product Stability Program : Develop, monitor and maintain stability data tracking systemEnsure timely receipt of the stability reports and manage their data-baseReview Stability Reports and address with the manufacturer identified risksMaintain site SOP on this subject, as required.
Develop and maintain Quality Assurance Agreements (QAgs) Develop, monitor and maintain the list of all required Quality Assurance Agreements 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 their timely review, revision and approvalConnect and negotiate with the parties involved into the QAg development, review enhancement and approval processAffiliate with Sun Pharma Legal department on review and requirements of the QAg to ensure appropriate language in the documentsMaintain with SOP on this subject, as required
Manage and execute Local Vendor Audit and Self-Inspection Program Develop Annual Audit and Self-Inspection Plan and obtain approval of the Associate Director, Quality AssuranceFor 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.
Responsible for Global Documentation Implementation Review the list of the global Quality Standards and SOPs and identify the list for implementationManage gap assessment process and ensure completion of all implementation associated activitiesProvide all completed forms for review and approval as per the established processDevelop and maintain site SOP on this subject, as required
Change Control Program Management Ensure review and approval of the change control records and their appropriate content, risk-based impact assessment and associated actionsEnsure appropriate personnel training and access in global QMS TrackwiseMaintain site SOP on this subject, as required.
Corrective Action and Preventive Action (CAPA) Program Develop and maintain Quality and Compliance metricsEnsure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement processOwn and execute CAPAs associated with Health Canada, Internal Audit and Self-Inspection observations
Sun Pharma Canada Inc. (SPCI) Training Program Management Establish training needs assessment process and identify training gapsDevelop, report and maintain training metricsManage the implementation of the Corporate Quality training courses and manage annual GMP training program as per training needs assessmentPrepare and maintain annual Integrated Training Calendar (ITC) and attend GMP forum meetings on behalf of the departmentAct as a Single Point of Contact (SPOC) for Sun Pharma Global Certification Programs and ensure their successful execution and effectivenessDevelop and maintain site SOP on this subject, as required.
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 7+ years of experience in Quality Assurance department working under Health Canada GMP regulations
Experience in dealing directly with Regulatory Agency officials (Health Canada)
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 20HRCN-QA-Manager-Sun-Canada - contract 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.