QA Qms Coordinator

2 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 various 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 manufacturer.

**Responsibilities**
- To work cooperatively with others for compliance with GMP regulations as required by Health Canada, The US FDA, or other Jurisdictions, in order to maintain GMP Status.
- Write and modify SOPs
- As required, participate in internal GMP and third-party audits.
- Investigate, prepare a report on Customer complaints and respond in a timely manner.
- As required, participate in examining the results, change controls requests when necessary, generate deviation reports, Investigate root cause determination, and provide recommendations for corrective actions/ CAPA.
- Review Certificate of analysis, Calibration reports, Batch manufacturing records, Batch Packaging records, and packaging SOI for any discrepancies, or errors, deviations and investigations (etc.) that could or may have the potential to affect the efficacy of the batch.
- As required, contact customers and internal departments to respond to their inquiries and resolve QA issues.
- Ensure to perform Risk Assessment using FMEA at every stage throughout the process when required.
- Review master manufacturing records and change controls for any changes in the ingredients, processing steps and equipment.
- Review SOPs, Bill of materials, customer signed PFSS documents and manage them in the ERP system.
- Prepare a report of Annual Product Review as per the clients request and respond to clients in a timely manner.
- Ensure all employees carry out Good Manufacturing Practices (GMP).
- Involve in the management of Waste disposals of Raw materials and Packaging materials.
- Coordinate with other RA employees to file the excise duty of alcohol.
- Act as an alternate person to issue Allergen statements to Finished Products and Raw Materials.
- Issues of GMP certificate to customers as per the sales department's request.
- Participate in other tasks that are assigned by the management.

**Preferred Qualifications and or /Experiences**
- Some post-secondary education (preferably university) in an applicable discipline such as biology, biochemistry, chemistry, engineering, nutritional studies, pharmacology, or medicine.
- Excellent communication skills and a familiarity with electronic software (e.g. Word and Excel).
- Two years of manufacturing or QA/QC experience in the pharmaceutical/nutraceutical or biotechnology industries.
- A good working knowledge of Canadian and USFDA GMP legal requirements would be considered an asset.
- Familiar with pharmaceutical quality management systems is an asset.

Pay: $45,000.00-$55,000.00 per year

**Benefits**:

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

Flexible language requirement:

- French not required

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 2 years (preferred)

Work Location: In person

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