Job Overview:
This is an exciting opportunity for a skilled validation professional to join our team and play a key role in ensuring the quality and reliability of our computerised equipment and control systems.
Key Responsibilities:
1. Develop and execute comprehensive validation strategies for new computerised equipment and control systems, including generating documentation and providing assistance with protocol execution.
2. Collaborate with cross-functional teams to ensure compliance with regulatory requirements, industry standards, and organisational policies.
3. Design, implement, and execute DQ, IQ, OQ, and PQ activities to verify the performance and functionality of equipment and systems.
4. Conduct thorough risk assessments to identify potential vulnerabilities and develop mitigation strategies to ensure the integrity of our processes.
5. Provide technical expertise on US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilisation.
6. Maintain accurate and detailed records of validation activities, including approving and implementing changes to relevant systems and generating validation/revalidation plans.
Requirements:
* Degree in Science (Chemistry, Micro., or Pharmacy) or Engineering (Chemical/Mech/Elec).
* Minimum 3-5 years of experience working in a Healthcare manufacturing environment, preferably in the pharmaceutical sector.
* 2-3 years of experience in a validation environment, with a strong understanding of regulatory requirements and industry standards.