Title:  Sr. Associate, QA - SUN

Date:  Jul 17, 2022
Location:  Sun Pharma Canada Inc
Company:  Sun Pharma Canada Inc

Position: Senior QA Associate                        Taro Pharmaceuticals Inc. is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: www.taro.com.

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

Our Brampton location is presently looking for Sr. Associate, QA

General Summary:

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, and 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, closeout and maintenance for internal and external issues.
  • Site Change Controls –  initiation, review, closeout and maintenance of all internal and external change controls.
  • CAPA Management – manages site CAPA program and ensures that 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.
  • Learning Management System (LMS) - Based on Learning Management System User role, act as SPCI Location Training Coordinator (LTC) according to established SOP.
  • Participate in all recall actions as required with regards to inventory management and documentation.

Knowledge Skills & Abilities 

  • Strong communication skills (written and oral) including presentation skills.
  • Proven problem solving ability with evidence of good judgment and decision-making skills.
  • 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 may 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.

      Background and Experience

  • 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.

Skills

  • Ability to prioritize workload, multi-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,

Working Conditions

  • Generally, pleasant surroundings.  Fairly level temperatures.  Mixture of sitting, standing and walking.
  • Demands on time.
  • Ability to support work on other shifts

 

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 Inc. 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 Inc. 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 Inc.  does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals Inc. 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 Inc. explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.