Manager, QA Gmp Audits

6 months ago

Milton, Canada Cencora Full time

- What you will be doing
- PRIMARY DUTIES AND RESPONSIBILITIES:

- Act as primary host for all Client GMP Audits, including scheduling, preparations, audit hosting, and preparation of Innomar’s audit response.
- Assist QA Senior Leadership in the hosting of all regulatory agency audits and any associated activities.
- Manage the internal audit program, including scheduling, audit preparation, audit execution, and audit resolution.
- Manage a team of QA Associates (as assigned) providing regular direction, mentoring, and coaching to the team.
- Support the management of the facility and equipment qualification programs, including temperature mapping of the warehouse, refrigerators and freezers, execution of lane studies, and validation of pack-outs.
- Assist the QA Management team in ensuring the completion of all compliance activities associated with the importation of drugs, medical devices and natural health products are executed in compliance with Health Canada’s regulations and guidelines.
- Assist the QA Management team in ensuring that Innomar’s warehouses and distribution centres remain in compliance with establishment licensing requirements.
- Assist the QA Management team in ensuring that deviation investigations are completed in a compliant manner, including report generation and any associated trend analysis.
- Provide support for the investigation of product quality complaints (PQCs), including report generation and any associated trend analysis.
- Assist the QA Management team in ensuring that change control requests are completed in a compliant manner, including change request generation, execution and close out, and any associated trend analysis.
- Provide support during recall / mock recall events (client and internal) as required.
- Develop effective relationships with Operations Management in order to ensure that the Milton Warehouse and Innomar DCs are maintained in a state of GMP compliance.
- Actively contribute to the development, maintenance, and improvement of the Innomar GMP Quality Systems.
- Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
- Demonstrate ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
- Provide leadership and direction to the QA team in the absence of the Director, QA GMP.
- Provide support as a member of QA Management for the development / revision and implementation of QA policies and procedures as required.
- Other duties and tasks that may be assigned by Senior QA Management.
What your background should look like
- EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

- Bachelor’s degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).
- Minimum of 6 years QA GMP experience.
- Note: Associates with a diploma in a pharmaceutical or healthcare related field, together with a minimum of 15 years’ QA GMP experience, will be considered to have met the technical qualification and experience requirements for this role.
- Minimum of 3 years’ experience in a supervisory role.
- Significant experience and a demonstrated expertise (i.e., minimum of 3 years’ experience and a minimum of 25 client audits) in the management and hosting of client GMP audits, regulatory agency inspections, and internal audits.
- Experience in the validation / qualification of equipment and facilities, including the preparation and execution of validation protocols and reports.
- Experience in the review and approval of GMP compliance related documentation and reports.
- Experience in conducting vendor audits is considered an asset.
- Experience in hosting/co-hosting client audits is considered an asset.
- Experience working in an Operations/Warehouse environment is considered an asset.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

- Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
- Demonstrated ability to thrive in a client facing role.
- Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
- The ability to identify pragmatic solutions to compliance / operational problems and challenges.
- Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
- Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
- Excellent written and verbal communication skills.
- May involve travel (up to 20%).
- May be required to be on standby / on call as part of this role.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive s

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