Validation Engineer
SIRE Group
- Hoofddorp, Noord-Holland
- Vast
- Voltijds
Our client is a prominent pharmaceutical company located in Hoofddorp, dedicated to revolutionizing healthcare through innovative therapies and treatments. With a focus on developing cutting-edge solutions for complex diseases, our client is committed to improving patient outcomes and quality of life globally. As a trusted leader in the pharmaceutical industry, our client values integrity, collaboration, and excellence in all aspects of their work.About the Role:
As a Validation Specialist for our client, you will play a pivotal role in ensuring the quality and compliance of our pharmaceutical products through meticulous validation processes. You will be responsible for executing and supporting validation projects, conducting commissioning and qualification protocols, and implementing corrective actions to uphold regulatory standards. This role demands keen attention to detail, analytical proficiency, and a comprehensive understanding of Good Manufacturing Practices (GMP) in the pharmaceutical industry.Key Responsibilities:
-Execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), including identification and resolution of exceptional conditions.
-Conduct temperature mapping and other validation activities to safeguard product quality and regulatory adherence.
-Investigate and implement corrective actions related to protocol exceptional conditions, CAPAs, and deviations.
-Collaborate with Quality Engineering to develop Computerized System Validation (CSV) strategies and procedures, encompassing risk assessments and user acceptance tests.
-Oversee contractors performing equipment and system commissioning, qualifications, and validation, ensuring alignment with company standards and regulatory obligations.
-Review technical documentation, such as protocols, summary reports, and validation SOPs, to maintain comprehensive validation lifecycle documentation.
-Report qualification activity status and progress to the Leadership team, offering insights and recommendations for continuous enhancement.
-Provide guidance on computerized system, equipment, and facility commissioning and qualification, and support vendor protocol executions as required.Required Experience:
-Extensive GMP experience in the pharmaceutical or relevant industries, demonstrating a firm grasp of regulatory requirements.
-Proven validation experience, encompassing the execution of commissioning, qualification, and validation protocols.
-Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
-Detail-oriented mindset with strong analytical and problem-solving capabilities.
-Proficiency in managing multiple projects concurrently and prioritizing tasks within a dynamic environment.Other information:
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