Senior QA Engineer ensuring quality across a data - heavy B2B product. Shaping test strategies and verifying correctness from UI to database integrations.
About the role
- Quality Assurance Validation Specialist at Grifols reviewing protocols and documentation to ensure regulatory compliance. Collaborating with engineers and teams in validation processes.
Responsibilities
- Review and approve IQ/OQ/PQ protocols and reports to ensure they meet internal standards and regulatory requirements.
- Ensure validation documentation is complete, accurate and traceable.
- Review work orders related to maintenance, calibration or qualification of equipment.
- Ensure all work is properly documented and compliant with Good Documentation Practices (GDP).
- Ensure validation activities comply with GMP, FDA, Health Canada or other applicable regulatory guidelines.
- Identify gaps or deficiencies in validation documentation and ensure appropriate corrective actions are taken.
- Work closely with validation engineers and the quality control, manufacturing and maintenance teams.
- Contribute to QA during the planning and execution phases of validation.
- Contribute to the development and improvement of validation procedures and templates.
- Participate in audits and inspections, providing validation documentation as required.
Requirements
- Bachelor's degree in a scientific discipline (minimum), preferably in microbiology, chemistry or biology.
- At least 2 to 3 years of experience in quality assurance 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).
- Good understanding of validation principles (IQ/OQ/PQ).
- Demonstrated judgment, technical competence and role-essential knowledge.
- Proficient computer skills with MS Office and Adobe Acrobat.
- Strong organizational skills, including attention to detail and the ability to meet deadlines.
- Ability to apply, follow and rigorously maintain rules, regulatory requirements, procedures and processes.
- Able to work independently and as part of a team.
- Able to multitask while collaborating to achieve and exceed objectives.
- Lead initiatives to improve company practices, processes and quality.
- Actively support and collaborate with colleagues.
- Facilitate cross-functional collaboration and manage assigned projects.
- Strong oral and written communication skills and good interpersonal abilities.
- Bilingual in French and English.
Benefits
- N/A
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