QA Coordinator

7 months ago

Richmond, Canada Viva Pharmaceutical Inc. Full time

**About us**

Our Company’s name **Viva Pharmaceutical Inc. **Since its inception in April 1994, Viva Pharmaceutical Inc. has built a reputation as a leading manufacturer committed to the production of custom-made pharmaceutical and natural health food products for its customers worldwide.

Viva Pharmaceutical Inc. creates natural products and ingredients aimed at helping consumers get and stay healthy. Those products are offered in a variety of popular forms - including softgel and hard-shell capsules, as well as traditional tablets. The company also offers custom manufacturing, private labeling, and testing services for retailers, resellers and manufacturers.

**Roles & Responsibilities**:

- Ensure compliance of equipment/machines at the site for qualification, validation, calibration, and preventive maintenance as per GMP and Health Canada regulations.
- Coordinate with Production and Engineering departments for qualification **(URS, FAT, SAT, DQ, IQ, OQ & PQ)** of new machines/equipment/instruments.
- Prepare and execute documents (protocols & reports) for equipment validation, qualification, and verification.
- Develop and update the Validation Master Plan and Calibration Master Plan.
- Conduct risk and impact assessments to identify, respond to, and monitor potential project risks, and develop contingency plans for risk mitigation.
- Collaborate with cross-functional departments to implement validation, calibration programs, and monthly preventive maintenance activities.
- Create, review, and implement SOPs for equipment operations, calibration, and preventive maintenance, and provide training for implementation.
- Participate in internal and external audits to ensure compliance with Health Canada regulations and other applicable regulations.
- Develop and implement quality policies related to calibration and preventive maintenance, ensuring staff engagement at all levels.
- Assist in change control management for the incorporation of new machines/equipment at the site.
- Maintain a master list for all equipment at the site and execute calibration and preventive maintenance as per the schedule.
- Coordinate with vendors (outsource service providers) for calibration and maintenance of equipment and utilities according to the schedule.
- Perform any other duties assigned by the QA/RA manager and senior management.

**Preferred Qualifications and/or Experiences**:

- B.Sc./M.Sc. degree or equivalent in an applicable discipline of engineering or science (chemistry, pharmaceutics, pharmacy, biochemistry, or related field), with specific training in equipment qualification/validation.
- Three or more years of experience in the pharmaceutical or nutraceutical industry, preferably in a validation/engineering role (previous experience in pharmaceutical manufacturing is a plus).
- Advanced knowledge/understanding of the Canadian regulatory framework for manufacturing, packaging, import/export of pharmaceutical/nutraceutical products (experience with Health Canada and US FDA regulations is advantageous).
- Strong follow-up skills, time management, project organizational skills, and research ability.
- Excellent communication skills and advanced proficiency in MS Office (Word, Excel, PDF, and PowerPoint).
- Familiarity with validation guidelines as per Health Canada and US FDA regulations.

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

**Benefits**:

- Casual dress
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- Richmond, BC: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Are you legally entitled to work in Canada?
- What are your salary expectations?

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Quality Assurance: 1 year (required)

Work Location: In person

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