Quality Compliance Associate

5 months ago

Steinbach, Canada Bausch Health Companies Full time

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

**ROLE TITLE**:COMPLIANCE ASSOCIATE (18 MONTH TERM)**

**DEPARTMENT**:QUALITY COMPLIANCE**

**REPORTS TO**:SUPERVISOR, QUALITY COMPLIANCE**

**HOURS**:8:00 - 16:30**

This role will provide guidance and regulatory expertise to facility personnel with respect to compliance expectations and participate in the facility internal audit program. Participate in the hosting of GMP regulatory inspections and customer audits. Manage suppliers through qualification, certification and external supplier audits and handle the creation and maintenance of quality agreements to ensure supplied materials/services meet quality standards. Review and approve facility validation protocols and reports. Support the execution of annual site GMP Training. Support the investigation of customer complaints.

**Responsibilities**:

- Ensure compliance with good manufacturing practices (cGMP) and regulatory requirements, and occupational health & safety.
- Participate in the hosting of regulatory inspection, customer, and third-party audits.
- Participate in the internal audit program.
- Analysis of site procedures in relation to global Quality policies, regulatory guidance, and implementing required updates.
- Provide guidance, and regulatory expertise as it relates to GMP, validation, compliance activities, and global quality policy requirements.
- Qualify and manage material suppliers and service providers through the supplier quality management, external supplier audit and quality agreement programs.
- Participate in investigations and risk assessments including customer complaints, nonconformance investigations and impurities risk assessments to support compliance requirements.
- Participate in the approval, management, and closure of the CAPA.
- Review and approve facility protocols and reports associated with validation activities for cleaning, computer systems, methods, and process validation, including qualification of equipment, analytical instruments, facilities, and utilities.
- Support the preparation of site reference files, technical reports, and annual product quality reviews.

**Education and Experience**:

- Bachelor of Science degree in a Life Science
- 5 years experience in a regulated pharmaceutical or health care environment; including experience in pharmaceutical audit programs
- Thorough experience and understanding of USA and Canadian cGMP, PIC/S, ICH, and validation requirements within a pharmaceutical environment
- Technical writing experience
- Knowledge of the internal, supplier and regulatory auditing process
- Working knowledge in Microsoft Office with a proficiency in Word, Excel, and database software

**Required competencies/Abilities**:

- Good verbal, and written communication skills
- Self-motivated, analytical, and high standards of integrity.
- Strong organizational skills with the ability to multi-task
- Sense of urgency and flexibility.
- Able to work with multiple internal and external stakeholders.

**Why Bausch Health?**

Bausch Health is a dynamic, growing company with a dedicated team committed to excellence and to helping Canadians by providing them with important, high-quality healthcare solutions. It is a progressive, exciting place to work where opportunities abound for current and new employees to help make a difference for Canadians.

We strongly believe the success of Bausch Health coincides with the achievement of personal and professional goals. We are a progressive, exciting place to work - where opportunities abound for new and current employees.

Our team members work in a dynamic environment where professional and personal growth is encouraged. You have the satisfaction of knowing that you are working with dedicated individuals who share a common vision of innovation and an unrelenting focus on improving people’s lives with our health care products.

By cultivating a winning attitude, we empower employees to seize opportunities that support the company’s mission to improve people’s lives.
- What we have to offer our employees in our state-of-the-art Steinbach manufacturing site:_
- Insurance coverage (Medical - Dental - Vision)
- Employee Assistance Program (EAP)
- Gym on site
- INSPIRE: Employee Recognition Program
- Full-service Cafeteria - Free coffee & tea
- Free parking
- The masculine is used in this publication without prejudice for th

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