QA Engineer Biotech industry, Breda, Noord-Brabant

Company:
This company is a global leader in the pharmaceutical and medical device industry, dedicated to ensuring the highest standards of quality, safety, and compliance. Our client specializes in innovative healthcare solutions and operates with a strong focus on GMP regulations and advanced manufacturing practices.

Job Description:
We are seeking an experienced Senior QA Associate to oversee quality assurance activities related to equipment validation, packaging processes, and master data management within a GMP environment. The role involves ensuring compliance with regulatory standards, supporting validation strategies, and maintaining the integrity of manufacturing data.

Responsibilities:

• Provide QA oversight for equipment and packaging validation activities, ensuring qualification processes meet regulatory and corporate standards.
• Review and approve validation documentation, including equipment qualification and process validation reports.
• Support testing strategies and investigate quality issues to ensure continuous improvement.
• Review and approve changes to equipment parameters and support documentation related to validation, manufacturing, and engineering modifications.
• Manage regulatory-compliant device responsibilities, including ABRs (Approval of Batch Records) and product combination devices.
• Review and approve master data entries within the PASX electronic batch record system to ensure accuracy and compliance.
• Conduct final reviews of technical change controls, verifying stakeholder assessments and documentation are complete.
• Act as the QA contact for deviation records, ensuring timely investigation and resolution.
• Collaborate with cross-functional teams to maintain GMP compliance and uphold quality standards across validation, engineering, and manufacturing processes.

Requirements:

• Bachelor’s degree in Life Sciences, Process Technology, or a related field (or equivalent experience).
• At least 3 years of relevant experience in the pharmaceutical or medical device industry, with a focus on equipment and automation validation.
• Solid knowledge of GMP, equipment validation, automation/IS validation, and computer compliance (e.g., Annex 11, Part 11).
• Good understanding of manufacturing and quality analytical processes.
• Fluent in English, with excellent communication and documentation skills.

Preferred:

• Experience working within the pharmaceutical industry.
• Knowledge of deviations and change control procedures.

Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.

56563