Overview
Reviewer, Documentation Quality Control Jobs in Brampton, Ontario, Canada at SUN PHARMA
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.
Knowledge, Skills and Abilities:
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
Problem Solving:
Recommends changes and requests investigations where required.
Any deviations to procedures or systems are brought to the Supervisor’s attention with logic, data and corrective measures.
Implement short range strategies and objectives towards enhancing the quality standards of the department and facility.
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
Working conditions
Generally the conditions are pleasant, not unlike normal office positions with fairly pleasant surroundings. There are infrequent exposures to higher than normal noise levels (when visiting plant). Mostly desk work with a mixture of standing and walking and some light lifting. Ability to work under stressful conditions and prioritize workload
Title: Reviewer, Documentation Quality Control
Company: SUN PHARMA
Location: Brampton, Ontario, Canada
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector)
