Document Reviewer - Mississauga, Canada - Reena Group

Reena Group

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Job Summary:

To conduct, with minimum supervision, reviews of tests of raw materials and finished products in accordance with current compendial and in-house procedures to assess the compliance with domestic and foreign regulatory requirements, as well as Canadian Analytical Laboratories standards.

Also to perform activities of the Quality Assurance department in strict accordance with all Standard Operating Procedures, GMP, company policies and procedures.

The key objective of this role is to work in all quality assurance systems and ensure they meet all relevant regulatory requirements of the pharmaceutical industry.

Key Responsibilities:

Review all test documentation for accuracy and completeness according to cGMP's
Responsible for timely and effective GMP review and release of analytical documentation in order to maintain a continuous pipeline flow of process of releasing the test results ensuring GMP and SOP's are followed
Adheres to internal/external guidelines, policies, procedures, specifications and regulatory requirements while reviewing and releasing analytical documentation
Addresses deficiencies to maintain consistent resolutions to all document review
Drives timely resolution of deviations related to analytical records, disposition of analytical data Reviews all batch documentation for accuracy and completeness according to cGMPs to ensure timely release
Evaluate OOS result Conduct OOS investigations
Review calibration data when required
Perform all other duties as assigned
Positively interacts with internal associates to quickly and effectively resolve issues
Addresses deficiencies and ensures completion of all followup actions according to GMP standards and company objectives
Review and maintain internal and external equipment calibration records
Manage all aspects of quality documentation issuance and returns inclusive of all laboratory logbooks and notebooks
Distribute SOPs and analytical procedures to laboratories and maintain QA documentation system.
Maintain the process for the execution, investigation and documentation of all laboratory OOS occurrences
Review stability protocols
Maintain records for appropriate retention times
Review standard receiving reports and approve reference standard labels
Maintain overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation

Minimum Requirements:

Degree in the Life Sciences preferably in chemistry or equivalent
At least 3 years' experience in the area of chemical test laboratory
Considerable knowledge of basic chemical concepts
Proven ability to work in a safe manner and maintaining a clean and organized work environment
Competency in clearly and fluently expressing concepts and ideas in English, orally and in writing
Ability to work as a member of a team and under minimum supervision

Laboratory Operations During COVID-19:

As an essential service provider, Canadian Analytical Laboratories is open to continue to support our community.

We continue to closely monitor the COVID-19 situation as well we are working to comply with advice being provided by both levels of the Canadian government.

Our parent company, Reena Group provides essential goods and services to the pharmaceutical, food, natural health products and medical cannabis industries, who are playing a pivotal role in responding to the crisis by ensuring the availability of products and supplies necessary to respond medically and economically both in Canada and the United States.

During this unprecedented time, our number one priority is the safety of our employees, customers and communities.

To continue to serve our laboratory client community, we have proactively adopted modified working practices, staggered working hours and taken all the warranted precautions to mitigate the risk of COVID-19 transmission and to ensure a safe environment to ensure that we comply with the principles of social distancing.

Job Types:
Full-time, Permanent

Benefits: