Specialist, Computer Validation

2 weeks ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**Title**:Specialist, Computer Validation**:

- Date: Mar 6, 2023- Location: Taro Pharmaceauticals CAN- Company: Taro Pharmaceuticals INC, CanadaTaro 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.

**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 approache

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