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
Why Join Alfasigma
- At Alfasigma, we foster a culture where the courage to innovate is key to our success.
- We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.
Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.
Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.
Apply now »
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