Specialist Quality Assurance (Technical Quality)
$63,000–$78,500 year
On-siteAll, Catalunya, Kingdom of Spain
Job Summary
Provide QA oversight for validation, engineering controls, and maintenance programs across equipment, facilities, utilities, and processes. Evaluate and approve validation documentation, including risk assessments, protocols, and traceability matrices, ensuring compliance with US FDA, Health Canada, and GMP standards. Collaborate cross-functionally with engineering, production, and IT teams to develop validation deliverables and implement change control procedures. Lead audits, non-conformance investigations, and CAPA plans while acting as a designate approver for technical documentation. Maintain up-to-date knowledge of regulatory trends and perform gap analyses on corporate guidelines.
Required Qualifications
- University degree in Science and /or Engineering
- 5 years' experience in a Pharmaceutical industry environment
- Detailed Knowledge of regulatory requirements for the pharmaceutical industry, including broad knowledge of Good Engineering Practices (GEP), Validation Lifecycle and Quality by Design (QbD)
- Strong Knowledge of Change Control Systems
- Working knowledge of 21 CFR Part 11, GAMP and GxP electronic systems and Data Integrity
- Familiar with industry applications such as Trackwise, SAP, Manufacturing Execution Systems and Validation tools
- Software skills (Microsoft Word, Excel, PowerPoint, Teams, Document management)
- Exceptional verbal and written communication skills, including technical report writing ability combined with project management foundations
- Computer literacy combined with broad technical knowledge and ability to understand and analyze technical systems (mechanical, electrical & scientific)
- Knowledge of the principles and application of current Good Manufacturing Practices (cGMP) specifically related to Commissioning & Qualification (C&Q) of facilities, utilities and equipment and Process/Cleaning Validation activities
- Ability to work both independently and in a team to achieve objectives
- Innovative quality-oriented mindset combined with strong problem-solving ability
- Comfortable multi-tasking, investigating and managing problems that can be more than routine in nature
- Extensive cross-functional collaboration with technical/scientific professionals, plant staff, admin staff, international counterparts (e.g. global quality)
- Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
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