Associate, Quality Management Systems

4 days ago

Aurora, Canada Piramal Healthcare Full time

**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**:

- EHS Focus
- Passionately Reliable
- Rapid Responsiveness
- Innovative Efficiency
- Teamwork
- Detail Orientation
- Excellent Customer Service
- Problem Solving

**Job Types**: Full-time, Permanent

**Benefits**:

- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
- Wellness program

Day range:

- Monday to Friday

Shift:

- Day shift

Ability to commute/relocate:

- Aurora, ON L4G 4C3: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

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