Senior Associate, Quality Assurance (Contract)

at  Taro Pharmaceuticals INC Canada

TITLE: SENIOR ASSOCIATE, QUALITY ASSURANCE (CONTRACT)

Date: Oct 7, 2024
Location: Taro Pharmaceauticals CAN
Company: Taro Pharmaceuticals INC, Canada
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
Employee training and organizational development programs, internal mobility programs, and employee recognition programs
Our Brampton location is presently looking for Senior Associate (Quality Assurance) (Contract)

QUALIFICATIONS

• Bachelor’s degree in Chemistry, Biology, applied science, or related field; or equivalent experience required.
• 5 - 7 years of experience in a quality regulated product manufacturing, packaging, laboratory or other technical experience required.
• 5 - 7 years of prior experience in a GMP and Health Canada regulated, Quality Assurance, Quality Control, or Compliance environment preferred.
• Experience in the consumer products and/or pharmaceutical field preferred.
• Experience in outsourcing of manufacturing/testing with track record of successful working with CMOs and third-party vendors.
• Knowledge/application of US FDA regulations, Health Canada regulations, guidance documents and validation requirements as it relates to Canadian compliance.
• Knowledge of associated functions including product testing safety, technical transfers and regulatory affairs.
• Experience with pharmaceutical (Rx/OTC) drug manufacturing, Canada products (NHP/DIN) and packaging, active pharmaceutical ingredients manufacturing, and analytical laboratories.
• FDA and Health Canada audit inspection experience, preferred.
• Demonstrates a thorough understanding and working knowledge of Quality Management Systems processes and tools.
• Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
• Demonstrated leadership skills in the areas of driving results, team collaboration, problem solving, and communication across functional areas.
• Demonstrated project management experience.
• Strong analytical data management skills.
• Excellent written and verbal communication skills.
• High proficiency with Microsoft Office (Excel, PowerPoint and Word).

PHYSICAL REQUIREMENTS

NA

JOB PURPOSE

The Senior Associate, Quality Assurance (Canada) is responsible for defined aspects of the day-to-day operational activities of The Proactiv Company’s (Alchemee) Quality Assurance function in Canada. This position will work across the entire spectrum of quality systems internally and external to the company including contract service providers (CSPs) and Contract Manufacturers (CMOs). The responsibilities will include implementing, troubleshooting, and continual improvement with development/approval of product specifications, change control documents, conduct/approve deviations, investigations, non-conformances, final product disposition and corrective and preventive actions (CAPAs) related to all Canadian Cosmetics, NHPs and drug product lots.

DUTIES AND RESPONSIBILITIES

• Manage relationship with CSPs/CMOs to assure product quality and GMP/Health Canada requirement standards are met.
• Initiate and manage change control documents, deviations, investigations, product specifications, non-conformances, and CAPAs related to all Canadian lots
• Oversee CMO/Third-party laboratory testing, reworks, stability program, SOPs, product quality related failures, trending report activities through quality indicating metrics.
• Perform internal audits, supplier/vendor audits, contract manufacturing/testing oversight and validation protocols.
• Manage the Annual Product Reviews (APQRs) process for Canada and support APR process for Alchemee US.
• Lead compliance efforts at Alchemee Canada and other GMP and Health Canada activities to assure all Alchemee Canada marketed products are compliant with applicable regulations.
• Manage all Health Canada requirements including: completing and submitting Alchemee Canada DEL applications to Health Canada;; requesting additional testing/retesting as required as per Health Canada regulations;; completing risk assessment for all Alchemee finish goods and raw materials, where required.
• Review and approve Canadian quality complaints and Canadian Reworks. • Prepare and maintain Table A for Canadian products.
• Prepare and submit Alchemee ALR (Annual License Renewals), and update/maintain quality agreements with all Alchemee wholesalers.
• Manage technical review and approval of specifications, protocols, procedures, analytical methods, stability, product quality manufacturing and related standards.
• Other duties as assigned