QA Specialist

3 months ago

Toronto, Canada Zenith PV Full time

Zenith PV Solutions Inc. is a leading provider of a full range pharmacovigilance services to the pharmaceutical industry in Canada. Our philosophy to provide the best quality of service and focus on client satisfaction has allowed us to grow rapidly through client referrals. As we grow our team to support our growing client base, we are looking for an experienced QA Specialist accountable for managing and maintaining the internal quality management system (QMS) and assisting with client-specific projects.

**Your Responsibilities and Impact**:

- Develop, implement, and maintain QA and PV related SOPs in accordance with company policies and procedures
- Maintain internal training records and documentations
- Responsible for handling and processing Product Technical Complaints in accordance as per established SOPs
- Manage Canadian batch releases of imported products as per the requirements of the Health Canada lot release program
- Coordinate with external departments such as 3PL warehouse for local lot release and daily operations
- Manage Canadian product recalls, including recall communications, strategy with Health Canada and customers.
- Conduct investigations on non-conformances and deviations.
- Identify, initiate, and follow through actions to implement change through a change control process
- Maintain compliance with current legislation on good distribution practices (GDP) and good manufacturing practices (GMP) for medicinal products
- Support GMP inspections, supplier audits and self-inspection programs including pre-inspection planning.
- Support Health Canada DEL renewal process & maintenance

**Required Qualifications for Success in this Role**:

- Bachelor of Science degree in Chemistry or Biology, with 5+ years of experience in Pharmaceutical Quality Assurance working under Health Canada GMP regulations
- Experience in maintaining QMS, PTC handling, deviations management, change controls, CAPAs, recalls, audit report. Canadian Experience is mandatory.
- Deep knowledge in Canadian batch release processes for pharmaceutical drugs. Biologic lot release experience is an asset.
- Continually update knowledge of the Health Canada Food and Drugs Act, Canadian Medical Devices Regulations, Drug Regulations and GMP
- Experience working with SAP is an asset.
- Strong communication and writing skills.
- Project Management Skills: Ability to prioritize and manage projects independently ensures efficient workflow and goal achievement.
- No excuses mindset and Adaptive Professional: Taking personal accountability to get the job done irrespective of unexpected external circumstances is a core skills. Equipped to adjust to evolving project needs, willing go above and beyond to meet client goals and satisfaction.

**Hiring Process**:
**Initial Step - Evaluating Skills**:

- Participate in an online assessment to gauge your expertise in QA.

**Next Step - Assessing Cultural Fit**:

- Engage in a virtual meeting with a senior executive to evaluate how well you align with our team dynamics and company culture. To excel in this stage, ensure you are well-versed in the specifics of the role and Zenith's mission. Maintain a professional demeanor, even in a virtual setting.

**Final Step - Purpose-Driven Evaluation**:

- Discuss your long-term career objectives and how they align with the position at Zenith.
- Share the story of your professional journey, including the discovery of your professional purpose and its relevance to your potential role with us.

**Feedback and Reflection**:
**Zenith's Commitment**:
We're committed to fostering a culture of excellence and integrity, where your contributions directly impact patient safety and client satisfaction.

Zenith PV Solutions Inc. is an equal opportunity employer, valuing diversity and inclusivity.

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

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Biologic Lot Release: 3 years (preferred)
- quality assurance: 3 years (preferred)

Work Location: Hybrid remote in Toronto, ON M5L 2A1

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