QA/ra 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.

**Responsibilities and Duties**:

- Maintain the manufacturing/packaging licensing (issued by Health Canada: Establishment and Site Licenses).
- Knowledge of the current regulations including latest amendments to ensure system and product compliance.
- Participate in internal GMP and third party audits.
- In a timely manner, provide technical reviews of legal document, including but not limited to: Quality Agreements, Manufacturing Agreements, Confidentiality Agreements, Non-disclosure Agreements, and Exclusivity Agreements.
- Review product labels and related promotional and advertising materials for domestic and export. Prepare annual summary report on adverse drug reaction of DIN products as outlined in Good Pharmacovigilance Practice.
- Prepare and submit annual drug notification to Health Canada.
- Ensure that the Company's programs and -products are compliant with the regulations, acts and associated policies of the Canadian federal government for Controlled Drugs and Substances Act (CDSA), including regulatory submissions, monthly and annually inventory reports, and coordination of responses to Health Canada.
- Execute monthly excise duty report on isopropyl alcohol and excise duty license renewal.
- Maintain Sanitation Program.
- Write and review SOPs to ensure continuous compliance with GMP and regulatory compliances. Maintain GMP and SOP training for all employees in the company.
- Maintain Sanitation Program.
- Ensure suitability of quality system by performing pharmacovigilance (PV) activities such as reception, evaluation and reporting of ADRs.
- Preparation of Annual Summary Report and Issue Related Summary Report writing and literature search.
- Logging customer complaints, performing risk assessment & writing investigation reports.
- Participating in internal audits for QMS & Pharmacovigilance system.
- Conducting training on GMP, GDP, GVP & other regulatory standards, maintain training records.
- Responsible for updating product label & Monograph in compliance of signal detection.
- Perform other duties as requested by QA/RA Manager.

**Preferred Qualifications and/or Experiences**:

- B.Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry or related), specific medical training (pharmacology, nutritional or related) or law.
- Three or more years of experience in the pharmaceutical or nutraceutical industry (previous experience in pharmaceutical manufacturing would be considered an asset).
- Advanced knowledge/understanding of Canadian regulatory issues for manufacturing/packaging of pharmaceutical/Nutraceutical products, (previous experience with Health Canada
- HPFB, TPD and NHPD would be considered an asset).
- Advanced knowledge/understanding of the regulatory requirements of foreign jurisdictions.
- Excellent communication skills and a familiarity with electronic presentation/report formats (e.g.Word, Excel and PowerPoint).
- Advanced knowledge of GMP and the US FDA regulations for manufacturing/packaging pharmaceutical or nutraceutical products.
- Demonstrated time management and project organizational skills.

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

**Salary**: $40,000.00-$48,000.00 per year

**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
- Day 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?

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Quality Assurance: 1 year (required)

Work Location: In person

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