I am looking for a Senior QA Specialist (Validation / QRM / Quality Engineering) for my biotech client in Breda.
Accountabilities
- Perform QA oversight for validation of equipment, automation, and information systems and for Quality Risk Management (QRM).
- Conduct review and approval of equipment and automation validation documentation, ensuring compliance with corporate, site, and regulatory requirements.
- Provide guidance and direction to operations staff regarding adherence to quality policies, standards, and procedures.
- Offer quality engineering support for testing strategies and quality investigations.
Responsibilities
Process, Equipment, and IS Validation
- Collaborate with Process Development (PD), Maintenance & Engineering (M&E), and Information Systems (IS) teams to agree on strategy and provide guidance on design, characterization, and validation, ensuring Good Manufacturing Practice (GMP) quality and compliance.
- Review and approve validation documentation.
Maintenance & Engineering Support
- Review and approve changes to equipment (e.g., parameter changes, assessments of like-for-like equipment replacements).
- Review and approve updates to M&E procedures, such as changeover processes and preventive/corrective maintenance activities.
Device and Combination Product
- Oversee device-related responsibilities and ensure alignment with GMP regulations.
Quality Risk Management (QRM)
- Represent QA in QRM activities (e.g., pFMEA, QRAES, Computer System Compliance).
- Align site quality risk activities with corporate policies and strategies.
- Review quality risk assessment summary reports.
Change Control
- Perform final review of technical change controls, confirming stakeholder assessments are complete and all tasks are accurately represented in the record.
- Act as the QA Subject Matter Expert (SME), gathering input from various QA areas to complete QA assessments for technical changes.
Qualifications
Minimum Requirements
- MBO or Bachelor’s degree in Life Sciences, Process Technology, or a related field, or an equivalent combination of education and experience.
- Typically requires 3 years of relevant experience in the pharmaceutical or medical device industry, with specific experience in Equipment and Automation Validation.
- Knowledge of GMP, equipment and automation/IS validation, and computer compliance (Annex 11, Part 11) with the ability to interpret and apply standards in routine cases.
- Familiarity with manufacturing and/or quality analytical processes and operations.
- Proficiency in English.
Preferred Requirements
- Experience in the pharmaceutical industry.
- Experience with nonconformance issues, CAPAs, and change control.
Competencies
- Strong logical and linear analytical skills to evaluate and interpret complex situations or problems using multiple sources of information.
- Good understanding of quality engineering tools.
- Ability to maintain an overview while performing detailed analysis when needed.
- Effective communication skills across multiple levels and departments, both within and outside Quality.
- Excellent attention to detail and strong writing skills.
- Good decision-making skills with the ability to apply a risk-based approach.
- Team player who works constructively toward solutions.
If you are interested in this opportunity, please send your CV to b.didomenico@panda-int.com today! Let's connect as soon as possible.
If you know someone who might be a good fit, feel free to introduce me to them. You can also refer a friend and earn €250,- for successful referrals.