Specialist, Computer Validation

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 , Taro's world class production facility is located in Brampton, Ontario, with a current team of over 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:

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.

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.

If you are interested in this opportunity, please submit your resume to referencing Compounder 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, , 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.