Reviewer, Documentation Quality Control

at  Taro Pharmaceuticals INC Canada

TITLE: REVIEWER, DOCUMENTATION QUALITY CONTROL

Date: Oct 29, 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 Reviewer, Documentation Quality Control

QUALIFICATIONS

• B. Sc. (Chemistry or Microbiology) or equivalent experience is required
• Minimum5 years experience with quality control laboratory background in pharmaceutical industry
• Quality Assurance and audit background in pharmaceutical industry would be an asset
• Proficient knowledge of applicable instruments (HPLC, GC experience preferred)
• Multi-tasking ability
• 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
• Demonstrated ability to apply analytical thinking, problem solving and detail orientation.
• Proficient knowledge of chemistry
• Excellent written and verbal communication skills
• Strong organizational skills to handle the high amount of documentation reviewed by this position
• Ability to work in a deadline-oriented environment

PHYSICAL REQUIREMENTS

Office based

JOB PURPOSE

The main responsibility of this position is to ensure through review of relevant documentation that all Taro products, bulk, finished goods, stability and raw materials and laboratory practices, meet the company and cGMP requirements before release for sale, manufacture or packaging.

DUTIES AND RESPONSIBILITIES

• Review all laboratory related documents to ensure that Quality Control Laboratory: finished products, bulk, raw material stability, and Microbiology meet Taro and GMP requirements prior to release
• Review accuracy of data entries in BPCS and/or LIMS
• Contribute and generate reports / performance metrics and data
• Automates job functions to achieve efficiency improvements
• Works with other departments to proactively build quality into the processes and systems
• 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.
• Assist personnel with documentation issues and provides coaching and guidance to Quality Control team.
• May be required to deliver technical training programs.
• Participate in activities supporting Laboratory Investigations
• Provide support for Regulatory Inspections
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.