Quality Consultant

Do you have a noticeable passion for results?

You’re bold, energetic, and very resourceful, especially when results are at stake. You have what it takes: a competitive drive coupled with the exceptional ability to communicate the value behind our client’s products and build lasting business relationships. Such talent and passion make you the right fit for this unique role with PEAK Pharma Solutions Inc.

Why PEAK Pharma Solutions?

Join a game-changing organization that is reinventing the way products and services are being introduced to the healthcare market in Canada. We bring a combined 50+ years of experience to this space, teaming with some of the most talented professionals and organizations in the industry. You’ll gain exposure to start-up as well as established healthcare companies in Canada.

Enjoy working in a dynamic environment where you’ll be supported with comprehensive yet simplified resources and processes. Grow your career with a company committed to transparency, integrity, and accountability. PEAK Pharma offers you more than just one job. The diversification and breadth of PEAK’s portfolio and network create a multitude of career paths and employment opportunities.

Job Description:

The Quality Assurance (QA) Consultant plays a crucial role in ensuring compliance with Canadian Good Manufacturing Practices (GMP) and related local regulations, maintaining the GxP status of the affiliate, and integrating global quality practices in the country. The individual will work closely with the responsible In-Market Quality Head to manage the local Quality Management System, identify and mitigate issues and risks, and ensure timely achievement of all In-Market Quality Assurance deliverables.

Key Responsibilities:

• Translate and articulate local Health Authority requirements and expectations, communicating effectively with local and global stakeholders.
• Perform final market release of commercial products, evaluating deviations' impact on pharmaceutical quality.
• Prepare and submit applications for Drug Establishment Licenses (DEL), maintaining DEL including the Annual License Review application.
• Maintain coordinated contact with local Regulatory Authorities and partners (suppliers, third parties, licensees, distributors).
• Manage a list of all local licenses and certificates in collaboration with Regulatory Affairs (RA).
• Interface with authorities in collaboration with RA as appropriate.
• Assemble and maintain Master Production Document for imported Finished Drug Products.
• Ensure readiness for GMP/GDP internal, external, and regulatory inspections.
• Address deficiencies identified through audits or other means, guiding timely implementation of corrective and preventive actions.
• Implement and maintain an effective and compliant Quality Management System according to our client's policies, corporate quality standards, global SOPs, Canadian GMP, and other applicable local regulatory requirements.
• Execution and Oversight of Local Quality Management System:
• Manage complaints, deviations, change controls, and CAPA according to our client's corporate SOPs and using relevant electronic systems, including oversight of KPIs.
• Execute periodic Management Review to ensure consistency and compliance with our client's procedures and local regulations, escalating potential issues to management.
• Conduct periodic Product Quality Review and Stability Review in accordance with MAH responsibility.
• Provide quality oversight to the Local 3PL in compliance with our client's Quality Standards.
• Execute internal and external audits as needed.
• Maintain Quality Manual.
• Lead local recalls and all related correspondence with national competent authorities.
• Ensure compliance to GMP/GDP and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable, driving a QA decision on the disposition of the product in case of deviations (including excursions).
• Ensure compliant final disposition of returned, rejected, recalled, or falsified products and authorization of return to saleable stock of any returned medicinal products.
• Ensure information and documents are maintained in the appropriate tools and that appropriate local archiving systems are in place.
• Ensure any additional requirements imposed on controlled or un-licensed medicinal products by national law are adhered to.
• Ensure all Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g., follow up and closure on all relevant complaints, deviations, and CAPAs, change controls).
• Proactively identify, assess objectively, mitigate, manage, and escalate potential risks to the line manager and implement agreed necessary actions to maximize opportunities or minimize risks. Engage with stakeholders to align on identified risk mitigation strategy.
• Ensure efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization, from the Territory to the Global QA organization and vice-versa, including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN).

Education/Competencies Requirements:

• Bachelor’s Degree, Minimum
• The requirements of the person in charge of quality control department as defined in Canadian GMP C.02.006 are met
• Solid knowledge of relevant local legal requirements of the pharmaceutical industry, including the interpretation and practical application of regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
• Has solid knowledge of international GMP/GDP requirements.
• Should be able to act in most circumstances without direct supervision and handle complex/difficult situations.
• Good quality auditing mindset, root cause and risk management/assessment skills.
• Must be able to effectively interact and communicate (verbally and written) with internal and external stakeholders on projects, product and quality related matters.
• Must have the ability to manage projects/ activities across the area. Be able to demonstrate professional maturity in difficult situations. Drive for results.
• Self-motivated team player, able to generate commitment and act as a role model for others in driving the area/company vision.
• Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
• Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.

Full PEAK Pharma Solutions compensation package which includes:

• Competitive compensation
• Full-time opportunity
• Allowances for expenses related to the role
• Dedicated training and support
• Opportunity to partner with a growing pharmaceutical organization in Canada.

We thank everyone that applies. If we feel your qualifications suit our current opportunity, we will be in touch with you. Please keep correspondence to email at this time.

PEAK Pharma Solutions is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Type: Full-time

Salary: $115,000.00-$130,000.00 per year

Benefits:

• Paid time off

Schedule:

• Monday to Friday

Education:

• Bachelor's Degree (required)

Experience:

• Pharmaceutical sales: 3 years (preferred)

Work Location: In person