Spécialiste, Assurance Qualité - Quality Assurance Specialist

GRIFOLS, S.A.•Montreal, QC

8d•Onsite

About The Position

Grifols is a global healthcare company that has been working since 1909 to improve the health and well-being of people around the world. They are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions. The company is seeking a Quality Assurance Specialist to join an international team dedicated to improving healthcare.

Requirements

At minimum, must have a B. Science
At least 2 - 3 years’ experience in QA 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)
Demonstrates judgment, technical competence and knowledge critical for role
Good computer skills with MS Office and Adobe Acrobat
Strong organizational skills, including attention to detail and ability to meet deadlines
Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
Must be able to work independently and as part of a team
Able to multi-task while collaborating to achieve and exceed goals
Leads improvement initiatives for organization's practices, processes and quality
Supports colleagues and actively engages with colleagues
Facilitates cross-functional collaboration and manages assigned projects
Good oral and written communication skills and good interpersonal skills
Bilingual in both French and English (mastery of English is required for documentation and communication with other Grifols sites outside Quebec and Canada (Spain, USA))

Nice To Haves

Bachelor's degree in Microbiology, Chemistry, or Biology

Responsibilities

Review of Deviations, Investigations, and CAPA
Review of procedure, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing and other departments
Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Change Requests, and Deviations, Investigations, and CAPA, as needed
Review/approval of quality systems such as Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects
Coordinate periodic review of procedures and other quality documents
Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
Ensure the integrity and traceability of all data generated and reported
Generate new procedures and revise existing procedures, as required
Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews
Provide cross departmental support to production, QC, validation and engineering
Develop and Report Quality Metrics for Deviations and other systems, as assigned
Perform additional Quality System program responsibilities as trained on and assigned