Career Connections Canada Inc.
'Connecting great people with great companies'
Our Brampton location is presently looking for an R&D Documentation Reviewer (contract 1 year)to join our team.
What Our Client Offers:
- A safe and clean; GMP regulated work environment
- Opportunities for career growth and development
- A competitive wage/salary
- Incentive bonus programs that are designed to reward employees for their individual contributions
- Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off
- Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs
The main purpose of this position is to:
- Ensure that the reviewed documentation of all R&D lab functions reflects that these are in compliance with cGMP and meet all approved procedures.
- All review work is done in effective manner and per plan.
Principal Duties and Responsibilities :
- Planning and prioritizing assigned document review workload to meetthe required lead times and due dates for CMC submissions.
- Ensure that all laboratory related documents for incoming goods, raw material, bulk, finished products, stability, calibration and analytical development and method validation are reviewed to meet company and cGMP requirements per assigned timelines and objectives.
- Review accuracy of data in Stability Application Software and Empower Software
- ReviewOOT/OOS investigations and assist in establishing the root cause
- Create, review and write SOPs pertaining to the group.
- Review current systems and procedures and implement changes where appropriate to improve accuracy andthroughput
- Complete all GMP Documentation correctly and in a timely manner.
- Complete all training assignments and maintain personal training records
- Complete Corrective and Preventive Actions (CAPA’s) as assigned.
- Initiate, and follow through with actions required to close Change Controls.
- Other duties as assigned.
Knowledge, Skills and Abilities
- Minimum of B.Sc. Chemistry
- About 5 years experience as an analyst in the pharmaceutical industry
- Minimum 1 year experience reviewing R&D documentation
- Thoroughknowledge of R&D pharmaceutical and laboratory operations
- Thorough knowledge of cGMP, GLP, FDA, TPP, HPLC, wet chemistry and/or microbiology functions
- Established record of quality work while performing Hands On activities (if applicable)
- Knowledge of analytical method validation.
- Knowledge of applicable software
- 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
- Effective organizational skills and ability to multi-task; detail oriented with ability to effectively close task and make decisions/recommendations as required.
- Problems associated with the supervision of any department (staffing, out-of-stock, procedures/practices, review of Out of Spec results)
***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Inc.**