Specialist, Computer Validation Jobs

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:

• Opportunities for career growth and development
• A safe and clean; GMP regulated work environment
• Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
• Incentive bonus programs that are designed to reward employees for their individual contributions
• A competitive wage/salary
• 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

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:

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

Knowledge, Skills and Abilities:

• Plans, organizes and monitors time and resources efficiently
• Team player with ability to work collaboratively with others, respects the input and know-how of other team members.
• Demonstrated knowledge of computer system validation processes using ISPE GAMP5 guideline and or other harmonized international guidelines (PIC/S, ICH) and GMPs
• 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
• 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)
• Strong knowledge of Health Canada and FDA regulations and GMP
• Excellent written and oral communication skills with ability to articulate messages to a variety of audiences
• Experience/Knowledge of supply chain business process is an asset
• Strong negotiation, and training skills, required to ensure that quality requirements are maintained while also meeting business expectations

Background and Experience:

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

Problem Solving:

• 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.
• 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.
• Negotiate with internal staff, contractors, consultants and vendors to ensure GMP sensitive systems are implemented and remain in a validated state.

Working Conditions:

• Wide variety of working conditions including all areas of the office and plant. On occasion, flexible hours of work may be required to support Validation Protocol execution. Some lifting may be required. Routinely a mixture of standing/walking/sitting will be required.
• Some travel required, primarily to Taro NY to support Validation initiatives / direction.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees in this job class. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Nothing herein shall preclude Taro Pharmaceuticals from changing these duties from time to time, and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

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.