Sr Associate, Quality Assurance Process Validation

Scope of the Role

The Senior Associate, QA Operations & Validation supports the execution, oversight, and continuous improvement of Quality Operations and QA Validation activities, ensuring full compliance with GMP requirements, internal procedures, regulatory expectations, and Quality Agreements with external manufacturing partners.

The role is responsible for supporting Process Validation and ICH Q3D-related activities, managing quality documentation associated with batch release, and contributing to the effective management of quality events. This position plays a critical role in ensuring the continuity of QA activities related to batch release, product quality, and regulatory compliance while collaborating with internal stakeholders and external manufacturers.

Your Role

As Senior Associate, QA Operations & Validation, you will:

• Support the management and execution of Process Validation activities and ICH Q3D requirements.
• Collect, review, and maintain all quality documentation required for product release, including Batch Records and supporting GMP documentation.
• Ensure manufacturing batch documentation is complete, accurate, and compliant with applicable regulatory requirements, GMP standards, and approved product dossiers.
• Support batch release activities in accordance with GMP requirements, internal quality procedures, and Quality Agreements with third-party manufacturers and clients.
• Collaborate with internal functions, suppliers, and contract manufacturers to manage production deviations, quality events, and product complaints.
• Participate in investigations related to deviations and complaints, supporting root cause analysis and the identification of corrective and preventive actions (CAPA).
• Follow up on CAPA implementation and verify the effectiveness of actions to ensure timely and sustainable resolution of quality issues.
• Maintain accurate and compliant quality records within company quality systems.
• Support continuous improvement initiatives aimed at strengthening Quality Operations, QA Validation processes, and overall GMP compliance.
• Contribute to cross-functional projects and initiatives that support business continuity, inspection readiness, and operational excellence.

Who You Are

• Degree in a scientific discipline, preferably Chemistry, Pharmaceutical Chemistry and Technology, Chemical Engineering, Biology, or Pharmaceutical Biotechnology.
• Proven experience in Quality Assurance within a pharmaceutical or life sciences environment.
• Solid understanding of GMP regulations, particularly within Quality Operations and QA Validation activities.
• Experience with quality documentation review and batch release processes.
• Knowledge of Process Validation principles and regulatory expectations.
• Familiarity with root cause analysis methodologies and CAPA management.
• Proficiency in quality and business systems such as TrackWise, SAP, Veeva, or equivalent platforms.
• Fluent in written and spoken English.
• Strong analytical and problem-solving skills, with a results-oriented approach.
• Ability to work independently while effectively managing priorities, deadlines, and multiple activities.
• High attention to detail, strong organizational skills, and proven capability in documentation management.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external partners.
• Team-oriented mindset, proactive attitude, and commitment to quality, compliance, and continuous improvement.

pay range: 36.000€ - 40.000€

The compensation range indicated in this job posting represents an estimated average range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements