Sr. Associate QA (Validation / Packaging / PASX master data) Breda • Talentmark

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We are looking for a Senior Associate QA to provide QA oversight for validation, packaging qualification, and PASX master data activities. You will join a supportive and collaborative team of seven QA professionals (soon eight) working on a wide range of technical projects that directly support production and compliance.

This position offers a dynamic environment with multiple parallel projects and opportunities to grow within a global biopharmaceutical company known for innovation and quality.

Key Accountabilities

• Provide QA oversight for equipment validation and packaging qualification.
• Review and approve equipment validation documentation in line with corporate, site, and regulatory standards.
• Provide QA support for testing strategies and quality investigations.
• Review and approve master data in the PASX electronic batch record platform.
• Perform final QA review of technical change controls, ensuring completeness and compliance.
• Act as QA SME (Subject Matter Expert) for risk assessments and support updates and reviews.
• Serve as QA contact for deviation management, especially for technical deviations.

Responsibilities
Process, Equipment, and IS Validation

• Align on validation strategies and provide guidance on design, characterization, and validation together with PD, M&E, and IS departments.
• Review and approve validation documentation.

Maintenance & Engineering Support

• Review and approve changes to equipment (e.g. parameter changes, like-for-like assessments).

Device and Combination Product

• Manage device-related QA responsibilities and ensure compliance with GMP regulations.

PASX Master Data

• Review and approve master data in the PASX system as part of QA responsibilities.

Change Control & Deviation Management

• Perform QA review and approval of change controls and deviations.
• Function as QA SME, collecting input from other QA areas and supporting risk-based decision-making.

Profile
Minimum Requirements

• MBO or Bachelor’s degree in Life Sciences, Process Technology, Engineering, or related field.
• Approximately 3 years of relevant experience in the pharmaceutical or medical device industry, preferably in equipment and automation validation.
• Solid understanding of GMP, Annex 11, and Part 11 compliance.
• Fluent in English (written and spoken).

Preferred Qualifications

• Experience with Deviations and Change Control.
• Experience in a pharmaceutical or highly regulated environment.
• Knowledge of computer system validation (CSV) and quality risk management is a plus.
• Familiarity with PASX or other electronic batch record systems is advantageous.

Personal Attributes

• Analytical and critical thinker with strong problem-solving skills.
• Curious and proactive, eager to understand processes in depth and ask the right questions.
• Strong communication skills across multiple teams and stakeholders.
• Able to manage multiple smaller projects simultaneously (4–6 at a time).
• Detail-oriented, yet capable of maintaining an overview and prioritizing effectively.
• Team player, adaptable and open to collaboration in a hybrid environment.
• Comfortable in a documentation-heavy, compliance-driven setting.

Additional Information from the Hiring Manager

• The team manages numerous technical projects (including new product introductions, production line changes, computerized system upgrades, and warehouse redesigns).
• Full-time availability (40 hours/week) is preferred.
• Training is extensive and structured, typically taking 6–9 months to gain full independence.
• The position offers long-term potential, with major projects planned for at least 2–3 years.
• The working atmosphere is collaborative and inclusive, with regular team activities.

Salary indication is €4354,05 – €4584,58 gross per month excl. 13th month, travel allowance, working from home allwance and vacation allowance.