- Position : Senior Associate, Quality Assurance (Sun Pharma)
- Department : Quality Assurance, Sun Pharma
- Requisition :
- Job Type : Full Time
- Posting Date : 01/22/2019
- 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 Senior Associate, Quality Assurance with our Sun Pharam team.
This position is responsible for monitoring various GMP related activities for company’s Canada business [i.e. product release and management of master documents from the CMOs, Deviation and OOS review, management of Change Controls, CAPA Management, Annual Confirmatory Testing].
Principal Duties and Responsibilities :
- Product Release to Canadian Market:
- Review of batch release and compliance documents required for imported product release in Canada
- Review batch documents for conformity with specifications and transportation conditions according to Health Canada requirements.
- Maintain supplier master documents.
- Maintain incoming inspection & release documents.
- Initiate and approve change control initiation for supplier critical and non-critical changes.
- Manage 3rd party lab testing for applicable products and manage annual confirmatory testing program..
- Schedule site priorities (i.e. collaborative review of incoming product for release to Canadian market for support to Supply Chain and Customer Service to fill orders).
- Co-ordinate warehouse QA activities for incoming inspection and release based on determined priorities.
- Review batch records, stability reports, validation reports, and associated documents required to comply with Canadian GMP.
- Interact with suppliers for receipt of release documents and supporting issues.
- Site Deviations – initiation, investigation, review, close-out and maintenance for internal and external issues.
- Site Change Controls – – initiation, review, close-out and maintenance of all internal and external change controls.
- CAPA Management – manages site CAPA program and ensures that r CAPAs based on deviations, complaints, audits, change controls are closed in a timely manner.
- SOP Management – oversees site GMP related SOPs , ensures they are followed and meet current corporate and regulatory requirements.
- Complaints - Provides QA support for complaint investigations.
- Returned Goods - Manages QA portion of the returns process per site SOP.
- Responsible for requesting/reparation/review of APQR’s.
- Participate in all recall actions as required with regards to inventory management and documentation.
Knowledge, Skills and Abilities
- University level degree (B.Sc.) in a Science or Pharmacy discipline acceptable to Health Canada standards.
- Minimum 5 years of relevant experience within the pharmaceutical industry, specifically in Quality Control / Quality Assurance, laboratory testing and handling of narcotic products.
- Strong communication skills (written and oral) including presentation skills.
- 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.
- Strong laboratory experience combined with Quality Assurance and Compliance background.
- Excellent working knowledge of GMP and regulatory requirements for the pharmaceutical industry.
- Strong proficiency with applicable computer software.
- Successful candidate will be required to undergo a police clearance process as required by the Health Canada, the Royal Canadian Mounted Police and Justice Canada guideline in reference to the sale and distribution of narcotics.
- Ability to prioritize workload, mulit-task and maintain compliance
- Ability to thoroughly review QA documentation to ensure acceptable compliance to regulatory expectations (e.g. deviations, OOS, CAPA and change controls)
- Attention to details and ability to make decisions based on scientific evaluations
- Problem solving and analytical skills
- High level computer literacy – word, excel, PPT, access and scientific tools
- Extensive inter-personal contact with other department professionals, plant staff, admin staff and international counterparts
If you are interested in this opportunity, please submit your resume to email@example.com referencing Senior Associate, QA (Sun Pharma) 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.