QA Specialist

4 weeks ago

Richmond, Canada Viva Pharmaceutical Inc. Full time

Our Company’s name is **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.

We currently looking for a person who carries dynamic, determined, and brave to accept challenging characters to join our Quality Assurance team.

**Responsibilities and Duties**:

- Ensure compliance with GMP regulations as required by Health Canada, the US FDA, or other jurisdictions in order to obtain GMP status (e.g. the Establishment License).
- Participate in Regulatory GMP, internal GMP and third-party audits.
- Approve analytical investigations of the out-of-specification, examine results, change control requests when necessary, generate deviation reports, root cause determination, and provide recommendation for corrective actions.
- Approve certificates of analysis, stability summary reports, calibration reports, analytical monographs, master batch records and packaging records in compliance with legal regulatory and customer requirements.
- Write, review and revise SOPs, quality policies and procedures, customer methods to ensure continuous compliance with GMP and regulatory compliance as well as customer requirements (on topics of regulatory compliance, liaise with the RA Manager in a cooperative team approach).
- Make decisions on release or rejection of materials (e.g. raw materials, packaging supplies and finished products) based on sound judgment and compliance to regulatory requirements, reports and specifications.
- Provide assistance and technical support for equipment or process optimization, validation, calibration, qualification or certification.
- Provide GMP and SOP training for all employees.
- Participate in other tasks that may be assigned by President & CEO and supervisors.

**Preferred Qualifications and/or Experiences**:

- A Canadian (or assessed as equivalent) B.Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry, chemical engineering, medicine or related).
- Ten or more years of QA experience in the pharmaceutical/nutraceutical related industry.
- Advanced knowledge of GMP and the US FDA regulations for manufacturing/packaging pharmaceutical or nutraceutical products.
- Familiarity with the regulatory requirements of foreign jurisdictions would be considered an asset.
- Able to work as a team leader and possess soft skills such as personnel integrity, and interpersonal skills.
- Proven ability to supervise personnel and excellent verbal/written communication skills.

**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: 10 years (required)

Work Location: One location

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