Associate, Validation

at  Taro Pharmaceuticals INC Canada

TITLE: ASSOCIATE, VALIDATION

Date: Mar 26, 2024
Location: Taro Pharmaceauticals CAN
Company: Taro Pharmaceuticals INC, Canada
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.com.

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.

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 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
• 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.

• 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.