Associate, Validation

7 months ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

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.

**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**:
The primary purpose is to generate, execute, modify and summarize validation documents for equipment, facilities (manufacturing and laboratory), manufacturing processes, cleaning and sanitizing processes at 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.

**Principal Duties and Responsibilities**:

- Write Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ/Process). Ensure protocols provide: 1) a high degree of assurance that a specific equipment or process will consistently produce a product meeting predetermined specifications and attributes, 2) assurance of the establishment of controls required by current Good Manufacturing Practices (cGMP).
- Responsible and accountable for the execution of Validation Protocols including: 1) observation and documentation of the equipment or process, 2) collection of samples, 3) coordination of testing and 4) coordination of third party services.
- 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.
- Perform equipment and process validation reviews as required.
- Write or revised Validation related SOP’s or Policies as required.
- 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.
- File and maintain Validation documentation archive ensuring prompt document retrieval when required.
- Manage effectively all assigned Validation projects.
- Establish strong relationships inter
- and intra-departmentally.
- Work proactively with other departments to ensure Validation requirements are met.
- Complete all GMP Documentation correctly and in a timely manner
- Complete all training assignments and maintain personal training records
- Train Taro personnel on protocol execution requirements as necessary.
- Participate in and/or lead Non Conformance Investigations, as necessary
- Complete Corrective and Preventive Actions (CAPA’s)
- Initiate, and follow through with actions required to close Change Controls
- Other duties as assigned.

**Knowledge, Skills and Abilities**:

- Strong project management and communication /writing skills
- Proficient computer skills and broad technical knowledge are required in order to provide value-added input into the Protocol development and execution process and to understand and analyze technical systems (mechanical, electrical & scientific).
- Knowledge of Change Control Systems.
- Exceptional verbal and written communication skills
- Innovative mindset combined with strong problem solving ability.

**Background and Experience**:

- Bachelor’s degree in Natural Science or Engineering (mechanical or chemical preferred)
- Minimum 2 years of pharmaceutical or relevant technical experience.

**Problem Solving**:

- Interact with relevant departments to assemble necessary documentation to support Validation activities.
- Assess impact of system changes (e.g., modify process) and recommend additional validation testing as necessary.
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