QA / Qc Manager (Pharmaceutical)

4 days ago

Vaughan, Canada Jaapharm Canada Inc. Full time

**Q.A. / Q.C. MANAGER (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. MANAGER**

Provide oversight and on-going development of QA System updates, QA In-Process for manufacturing and packaging, the Quality Assurance in Label Control, Health Canada Inspection & release of a drug product.
- **Responsibilities**:_
- Reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.
- Conducting compliance audits and product release in accordance with cGMP.
- Support process validation.
- Write & review SOPs on the operation & maintenance of packaging & manufacturing of solid dosage products.
- Conduct & participate in self inspections in accordance with cGMP.
- Review and approve change controls and assure proper & timely completion of audits.
- Checking and completing Packaging product room Start up & Closing documents.
- Updating all daily, weekly & monthly Maintenance Report.
- Assure compliance to all Regulatory and Corporate guidelines and requirements.
- Typical Quality Control functions such as reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.
- Approves raw materials, packaging, and labeling materials.
- Investigates and records complaints.
- Reviews Analytical Data.
- Ensures correct reconciliation (product, label)
- Investigates processes (Out-of-Specification test results and deviations)
- **Requirements**:_
- Must have B. Sc (Chemistry or Health Sciences) degree and approved course in Quality Assurance.
- Minimum of 1 to 2 years Quality Assurance experience in the pharmaceutical industry relating to prescription or non-prescription drugs for sale in Canada a must.
- Participation in Health Canada Inspection as a QA/QC Manager or a team leader in relation to prescription or non-prescription drugs a must.
- 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.

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

**Salary**: $76,000.00-$115,000.00 per year

Schedule:

- 8 hour shift

COVID-19 considerations:
Everyone is required to wear face mask in the premises. Hand sanitizing protocol followed at the facility. Social distance to be maintained at all times in the premises. Should be fully vaccinated.

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality Assurance experience in pharmaceutical industry: 1 year (preferred)

**Language**:

- English (preferred)

Work Location: One location

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