Title: Specialist, Validation

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 Specialist, Validation

The Validation Specialist is responsible to lead validation activities and provide expertise for the generation, execution, modification and summation of Validation documents of equipment (manufacturing and laboratory), processes, cleaning, sanitizing and facilities aspects of Taro's manufacturing site that may affect the quality of the product produced or tested. This is accomplished through interaction and co-ordination of activities with all relevant departments within the organization.

Duties and responsibilities

• Ensure validation programs are established and maintained and provides feedback to generate accurate lists to ensure Master Plan objectives and schedules are met working within the constraints established by the production schedule.
• Prepare Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). Ensure protocols provide:

• Responsible and accountable for the execution of Validation Protocols including:

• Write reports that summarize and assess impact of the results generated through the Validation Protocols. Where required, recommend corrective measure(s) with the objective of attaining validated status.

• Evaluate new equipment from a validation perspective through participation on the equipment selection team with engineering to ensure that new purchases will be capable of meeting validation requirements.

• Write & revise Validation related SOP's or Policies, make suggestion for improvement of current SOPs as required.

• Assist in planning Validation program schedules.
• Train Taro personnel on validation related SOPs as required.
• Establish strong relationships inter- and intra-departmentally and provide leadership and guidance.
• Maintain Validation documentation archive ensuring prompt document retrieval when required.
• Prepare reports on Validation activities or Pharmaceutical Technology studies as required.

Qualifications

• High caliber verbal and written communication, including technical report writing ability and project management foundations are required to manage assigned Validation projects effectively.

• Computer literacy, and broad technical knowledge and ability to understand and analyze technical systems (mechanical, electrical & scientific) is required in order to provide value-added input into the Protocol development and execution process.
• Knowledge of the principles and application of current Good Manufacturing Practices guidelines related to Validation activities is essential, as is the ability to work both independently and in a team to achieve objectives.
  • Bachelor's degree in Natural Science or Engineering (mechanical or chemical preferred)
  • 5 years of pharmaceutical or relevant technical experience, including experience in at minimum; two of the following; cleaning, facility, and/or process validation programs.
  • Minimum 3 years’ experience with Installation, Operational and Performance Qualifications
  • Communication and project management skills, technical report writing, ability to understand and analyze technical systems.
  
  

Working conditions

Variety of working environments, including all areas of the office and plant. Occasional exposure to chemicals and higher or lower than normal temperatures. On occasion flexible hours of work may be required to support Validation Protocol execution. Routinely a mixture of standing/walking/sitting is required.

Physical requirements

Some lifting may be required

Direct reports

N/A

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.