QA Specialist - Deviation and CAPA
About The Position
A proudly Canadian company, Sentrex Health Solutions is a fully integrated specialty distributor and patient support provider for pharmaceutical manufacturers, physicians, and their patients. We provide innovative solutions focused on ensuring patients have access and the support they need to maximize their treatment outcomes. We do this through strategic distribution models and patient support programs that are backed by powerful, integrated technology, a dedicated in-house creative agency, and experienced, cross-functional teams. Our core capabilities include Specialty Pharmacy Services, Customized Solutions for Warehouse, Wholesale & Distribution, Patient Support Programs, Strategic Creative Services as well as HCP & Clinic Services. The QA Specialist – Deviation and CAPA role is based in our facility in Markham and the key functions include supporting the Senior Manager, Quality Assurance and working with cross-functional teams to ensure the Quality Management System (QMS) is being followed. They will be leading the investigation and documentation into deviations and CAPAs related to GVP, GMP, CSV and contractual requirements. This role is also responsible for trending, metrics and training. Preparing and/or presenting on trending and metrics to senior leadership may also be required. Occasional support for internal audits is required. They will also be an ambassador for the quality culture in Sentrex.
Requirements
- A Bachelor of Science degree in Chemistry, Biochemistry, Biology or other related discipline
- A minimum of three (3) to five (5) years of knowledge and working experience in pharmaceutical quality assurance
- A minimum of three (3) years leading deviation and CAPA investigations.
- Well organized and detail oriented.
- Thorough knowledge and understanding of Canadian (Health Canada) Food and Drug Regulations and guidelines.
- Experience with GMP, GVP, GCP, ICH regulations, and guidelines.
- Excellent English verbal and written communication skills.
Nice To Haves
- Experience with PSP – Patient Support Programs is an asset.
- Experience with ZenQMS or other QMS software is an asset.
- Bilingualism (French/English) is considered an asset.
Responsibilities
- Leading investigations into deviations related to GVP, GMP, GCP or CSV issues.
- Determining the impact of deviations (minor, major, or critical) on product quality and patient safety.
- Trending deviations in real time and periodically as part of continuous improvement to look for Opportunities.
- Measure metrics related to deviations and Capas on a routine basis, assign actions to address any negative trends in metrics.
- Present on deviations to senior leadership as requested.
- Oversee the deviation process including ensuring timely initiation and deviations are being completed in compliance with Sentrex and client procedures.
- Developing and overseeing Corrective and Preventive Actions to prevent recurrence.
- Ensuring all deviations are documented, reviewed, and approved by Quality Assurance (QA) in a timely manner.
- Approving deviations on behalf of QA.
- Maintaining compliance with Health Canada and client contractual requirements to ensure we are always in an audit ready state.
- Working with PSP, PV, IT, WH, and quality teams to resolve issues.
- Ensure all deviation and CAPA procedures are compliant and current.
- Develop and deliver training to ensure users and QA team members are trained on the deviation and Capa process.
- Any other responsibilities as determined by the manager.
Benefits
- Competitive Salary and generous vacation entitlement
- Wellness Program (5 paid days off for your well-being!)
- Paid Sick Days
- Competitive Benefits Package including Dental & Extended Health Benefits, AD&D, LTD & Employee/Dependent Life Insurance
- Employee & Family Assistance Program
- RRSP Matching Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
