Analyst, Quality Control Development

at  Taro Pharmaceuticals INC Canada

TITLE: ANALYST, QUALITY CONTROL DEVELOPMENT

Date: Sep 9, 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 Analyst, Quality Control Development

QUALIFICATIONS

• Bachelor’s Degree in Chemistry, or related discipline
• 3-5 years’ experience in the pharmaceutical industry in a Quality Control Laboratory.
• Knowledge of Pharmaceutical Manufacturing and Packaging an asset
• Demonstrated technical writing skills
• Well-developed interpersonal and teamwork skills
• Expert knowledge and understanding of analytical chemistry and instrumentation
• Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC)
• Knowledge of applicable software including LIMS, Empower and MS Office
• Sound knowledge and application of Health Canada and FDA regulations
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Strong organizational skills and ability to multi-task; detail oriented
• Excellent problem solving and judgment
• Advanced ability in investigative techniques to troubleshoot analytical problems
• Recommends changes and requests investigations where required.
• Any deviations to procedures or systems are brought to the Management’s attention with logic, data and corrective measures

PHYSICAL REQUIREMENTS

Office based

JOB PURPOSE

The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).

DUTIES AND RESPONSIBILITIES

• Develop and validate methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods.
• Develop and validate cleaning validation methods as required.
• IV Drug release testing for product comparison.
• Perform process validation and cleaning validation testing.
• Perform method transfer activities.
• Support new product introduction.
• Product, method and raw material trouble shooting.
• Participate on projects in the area of focus related to process improvement.
• Collaborate with other departments to proactively build quality into the processes and systems.
• Create and revise QC procedures as required.
• Provide support for internal and Regulatory Inspections.
• Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
• Generate, gather and analyze data for reporting purposes.
• Complete all GMP Documentation correctly and in a timely manner.
• Complete all training assignments and maintain personal training records.
• Participate in and/or lead Non Conformance Investigations.
• Complete Corrective and Preventive Actions (CAPA’s).
• Initiate, and follow through with actions required to close Change Controls.
• Participate in Internal, Customer and Regulatory Audits.
• Other duties as assigned.
• Maintain a clean laboratory environment and ensure that safety regulations are followed
• Complete all training assignment and maintain personal training records.
• Flexibility to work shift schedules when required
• Other duties as assigned