QA / Qc (Pharmaceutical)

2 weeks ago

Vaughan, Canada Jaapharm Canada Inc. Full time

**Q.A. / Q.C. (PHARMACEUTICAL)**

Jaapharm Canada Inc.

Woodbridge (Vaughan), ON, Canada

Jaapharm located near Hwy. 7 & Weston Road specializes in solid dosage pharmaceutical products, in-house research, manufacturing, packaging and testing. 80% of total budget in R&D, relates to analytical chemistry method development and compression process development, at present relating to prescription & OTC drugs.

Founded in 1988, Jaapharm’s focus is directed towards the research in compression (tablet) & analytical method validation for raw material & finish products relating to compression.

**Q.A. / Q.C.**

Provide oversight and on-going development of QA System updates, QA In-Process for manufacturing and packaging of Non-prescription drugs, the Quality Assurance in release of product.
- **Requirements**:_
- Participation in at least 1 Health Canada Inspection as a QA/QC team member or a team leader in relation to Non-prescription Drugs or Natural Health Products **a must**.
- B. Sc (Chemistry or Health Sciences) degree and approved course in Quality Assurance.
- Ability to manage multiple projects and tasks concurrently and effectively.
- Sound understanding of cGMP and ICH requirements.
- Excellent written and oral communication skills is a must.
- Computer proficiency with MS Office programs.
- **Responsibilities**:_
- Conduct & participate in self inspections in accordance with cGMP.
- Review and approve change controls and assure proper & timely completion of audits.
- Reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.
- Write & review SOPs on the operation & maintenance of packaging & manufacturing of solid dosage products.
- Maintaining all daily, weekly & monthly Maintenance Reports.
- Assure compliance with all Health Canada guidelines and requirements.
- Approves raw materials, packaging, and labeling materials.
- Reviews Analytical Data.
- Investigates processes (Out-of-Specification test results and deviations)
- Perform product recall and regulatory communication related to it.
- Be the primary liaison between the regulatory bodies (e.g., Health Canada) and Jaapharm on all communications.
- Ensure that all work is in compliance with GMP, GLP, SOPs and regulatory requirements (marketing authorization) and established safety standards.
- Ensure that batch that is released meets the regulatory requirements.
- Ensure that all manufacturing and packaging documents are complete, all the tests have been performed.

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

**Salary**: $70,000.00-$90,000.00 per year

Schedule:

- 8 hour shift

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality Assurance experience in pharmaceutical industry: 2 years (preferred)

**Language**:

- English (preferred)

Work Location: In person

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