Title:  Specialist, Cmp Validatn

Date:  Jun 22, 2022
Location:  Taro Pharmaceauticals CAN
Company:  Taro Pharmaceuticals INC, Canada

Taro Pharmaceuticals 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.ca.

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

 

General Summary:

A leadership role in the implementation of  computer systems validation methodology as per the approved company policies and procedures.

 

Principal Duties and Responsibilities:

 

  • Lead Global Computer Validation Activities for systems implemented at multiple Taro sites.
  • Lead Computer Validation Activities across multiple departments at the site level.
  • Validation of computer systems including hardware and software to support business systems that have GMP impact
  • Write computer validation plans and protocols addressing all critical functions requiring validation
  • Review of Validation deliverables including URS, FRS, Migration Plans, Configuration Specification, etc.
  • Address deviations associated with Computer System Validation for business/GxP  impact and resolution.
  • Write reports to  summarize the results computer validation activities
  • Recommend corrective measures with the objective of meeting validation requirements when required
  • Evaluate system(s) changes using a risk based approach and assign appropriate level of validation requirements
  • Ensure compliance is established and maintained at all times
  • Write and maintain computer validation related SOPs and/or policies as required
  • Maintain electronic and paper computer validation documentation to ensure prompt document retrieval when required
  • Effectively manage all assigned computer validation projects
  • Train employees on computer validation related  activities and SOPs as required
  • Keep current with industry and regulatory guidelines
  • Flexibility to work overtime when required
  • Participate in periodic review of Computer Systems
  • Other duties as assigned

 

 

Knowledge, Skills and Abilities:

 

  • Demonstrated knowledge of computer system validation processes using ISPE GAMP5 guideline and or other harmonized international guidelines (PIC/S, ICH) and GMPs
  • Experience/Knowledge of supply chain business process is an asset
  • Strong knowledge of Health Canada and FDA regulations and GMP
  • Ability to establish and maintain trusted and respected relationships with all  internal and external stakeholders and influence others to move toward a common vision or goal
  • Team player with ability to work collaboratively with others, respects the input and know-how of other team members.
  • Excellent written and oral communication skills with ability to articulate messages to a variety of audiences
  • Strong negotiation, and training skills, required to ensure that quality requirements are maintained while also meeting business expectations
  • Report writing skills
  • Strong organizational, multi-tasking, detail oriented, problem solving and root cause identification skills.
  • Demonstrated understanding of all quality systems (training documentation change control validation vendor management and internal and external audits)
  • Plans, organizes and monitors time and resources efficiently

 

 

Background and Experience:

 

  • Bachelors Degree required, preferably in Computer Science or Engineering
  • Minimum 5 years experience working in a pharmaceutical-related field or medical devices field
  • Minimum 5 years experience in a computer validation capacity
  • Minimum 5 years of demonstrated project management experience including project management approaches, tools and phases of the project lifecycle

 

 

Problem Solving:

 

  • Priority setting within an entrepreneurial client community, a rapidly growing and changing company, and a wide and varied set of client requests for new or enhanced functionality.
  • Integration of the prerequisite steps of Validation into a Project plan, educating the project team on the requirements and timeframes to satisfy those steps, helping to manage and in many cases managing the project timeline.
  • Negotiate with internal staff, contractors, consultants and vendors to ensure GMP sensitive systems are implemented and remain in a validated state.

 

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.