Key skills
SAPCommunication
About this role
Role Overview
- Perform the following daily functions, but not limited to: review deviations, investigations and CAPA;
- Review procedures, batch production records (BPR), logbooks, reports and any documentation generated by Manufacturing and other departments;
- Review/approve quality
- and operations-related activities and documents (logbooks, room/equipment status, training records, investigations, etc.) related to change requests, deviations, investigations and CAPA, as required;
- Review/approve quality systems such as deviation management, quarantine, lot release, SAP, the SAP Quality module, documentation, and provide quality input for validation projects;
- Coordinate the periodic review of procedures and other quality documents;
- Initiate deviations, investigations, CAPA and change requests related to GMP documents/processes, as required;
- Ensure the integrity and traceability of all generated and reported data;
- Generate new procedures and revise existing procedures, as needed;
- Gather data on deviations, investigations, CAPA and change requests for annual product reviews;
- Provide support to other departments such as Production, Quality Control, Validation and Engineering;
- Develop and report quality metrics for deviations and other systems, as assigned.
Requirements
- Bachelor of Science degree minimum (preferably in Microbiology, Chemistry, or Biology);
- At least 2 to 3 years of Quality Assurance experience within the biopharmaceutical or pharmaceutical manufacturing industry;
- Specialist-level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments);
- Proficient computer skills with MS Office and Adobe Acrobat;
- Strong organizational skills, including attention to detail and ability to meet deadlines;
- Able to apply, follow and rigorously maintain rules, regulatory requirements, procedures and processes;
- Able to work independently and as part of a team;
- Capable of multitasking while collaborating to meet and exceed objectives;
- Lead initiatives to improve company practices, processes and product quality;
- Strong verbal and written communication skills and good interpersonal abilities;
- Bilingual in French and English (fluent).
Benefits
- Health insurance
- Flexible work arrangements