Associate, Quality Management Systems - Aurora, Canada - Piramal Healthcare

Piramal Healthcare

Verified Company

Aurora, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

JOB PURPOSE:

Assist the QMS Leader and the Sr. Quality and Compliance Manager in ensuring compliance with regulatory requirements, company's Quality Systems and cGMP requirements.

JOB RESPONSIBILITIES:

Monitor, track and improve QMS metrics (CAPA's, Deviations, Quality Metrics, Quality Agreements, vendor qualifications, change controls, etc).
Review and maintain documents related to Quality Systems (CAPAs, deviations, risk assessments, investigations, change controls, etc.)
Maintain systems and act as SME for Trackwise, Ensur and other eQMS
Perform data integrity assessments and participate in the maintenance of the Data and Management Integrity program
Identify and implement continuous improvements for the elements of the quality system related to operations and laboratories operations.
Contribute to the writing, coordination, review, approval and maintenance of SOPs and policies.
Conduct Gap Assessments with corporate guidelines and regulatory requirements and develop and implement mitigation plans
Perform internal and external audits and support regulatory inspections.
Perform housekeeping inspections, regular walkthrough the operations and laboratories areas to ensure compliance with written procedures.
Perform routine QMS metric analysis. Prepare metrics and perform trend analysis in support of quality management review.
Participate in the review of facility, equipment, instrumentation, and computerized systems related documents, such as qualifications and validations
Conduct GMP, Data Integrity and QMS training of site employees, document and maintain training records. Develop and maintain training modules.
Prepare, participate, facilitate and respond to regulatory agencies inspections
Participate in quality and compliance improvement projects
Perform other related assignments and projects as required

EDUCATIONAL AND PROFESSIONAL ATTAINMENT:

B.Sc. in Chemistry or related scientific discipline with a minimum of 5 years experience or
M.Sc. in Chemistry or related scientific discipline with a minimum of 2 years experience

MINIMUM JOB RELATED WORK EXPERIENCE REQUIRED:

A minimum of 5 years experience in a Quality Assurance role within the pharmaceutical and/or API manufacturing industry.

SKILLS AND KNOWLEDGE:

Extensive knowledge of cGMP and pharmaceutical industry operations (manufacturing and laboratories)
Strong understanding and operating knowledge of HC, FDA and ICH regulations.
Proficient in Trackwise, Ensur and other QMS
Clear and concise oral and written communication skills

CRITICAL ATTRIBUTES: