Systems Quality Engineer investigating software, systems, and hardware interaction issues for Kardium’s atrial fibrillation medical device. Driving root - cause analysis and product reliability improvements.
About the role
- Manager leading R&D quality assurance for Apotex, a Canadian global health company developing affordable medicines. Overseeing GMP compliance, batch disposition, investigations, audits, and QA staff.
Responsibilities
- Manage ongoing QA activities supporting business and GMP compliance needs of manufacturing, packaging and laboratory operations in Product Development
- Interact with Richmond Hill R&D manufacturing/packaging groups, laboratories and R&D Project Management to determine scheduled activities and manufacturing schedule changes
- Oversee assignment of work for review and approval of R&D manufacturing/packaging masters and executed batch documents
- Review and approve R&D specifications, test results, experimental raw materials, and non-commercial finished product batches including IMPs and submission batches
- Provide leadership and operational oversight for records and processes supporting 21 CFR Part 4 requirements for Combination Products
- Review and approve master manufacturing/packaging masters, executed batch records, and regulatory submission documents
- Coordinate and approve deviation investigations, CAPA, and complaint investigations for IMPs
- Review and approve change controls for manufacturing/packaging documents, analytical methods, specifications, SAP material codes, SAP Master Data, SOPs, and other controlled documents
- Implement appropriate processes and continuous improvement initiatives to maintain effective quality standards in R&D
- Lead preparation for and provide support during and after regulatory or customer inspections
- Support and manage the R&D self-inspection program at Richmond Hill
- Serve as primary contact and consultant for quality issues pertaining to R&D operations
- Conduct resource planning analysis for headcount forecasts with the Associate Director, CMC QA
- Lead performance conversations, support employee development, remove barriers, and reinforce performance expectations
- Create a culture valuing trust, employee development, growth, collaboration, courage, perseverance, and passion
- Attract, hire, and onboard talent
- Ensure direct reports adhere to compliance programs and company policies and procedures
- Perform other duties as assigned
Requirements
- Sc. in Chemistry, Microbiology or related science
- Thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D for pharmaceutical liquid dosage forms
- Strong understanding of regulatory requirements for IMPs and registration batches
- Excellent interpersonal skills with recognized leadership ability
- Demonstrated ability to handle multiple work assignments
- Experience with technical report writing / scientific documentation
- Minimum six (6) years of QA experience in the pharmaceutical industry
- Three (3) years of supervisory experience, preferably in a QA role
Benefits
- Bonus programs based on position in the organization
- Pay-for-performance philosophy
- Comprehensive benefits
- Pension plan
- Learning and development opportunities
- Accommodation for applicants with disabilities
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