Our Multinational Healthcare Client has a requirement for a Validation Engineer

Duties:

• To manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation)
• To develop, maintain and take responsibility for the cleaning validation strategy
• To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU
• Implementation of Process Validation of new products
• Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams
• Establishing, implementing and directing validation and revalidation activities
• Reviewing and managing Change Control Forms for Validation/Compliance implications
• Conduct Routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
• Identifying training requirements in support of validation
• Ensuring completion of validation protocols
• Maintaining validation documentation system
• Perform Product Quality Review ensuring timely completion of PQRs and adherence to schedule and GMP requirements.
• Assist in the investigation of Customer Complaints as required.
• Review/lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.

REQUIREMENTS

• Bachelor's degree in Science, Engineering, Technology or a related discipline.
• 4-5 years validation experience working within a Pharmaceutical Manufacturing Environment.
• Industry knowledge of the requirements of EU GMP (IMB/FDA).
• Experience and knowledge of solid oral dosage processes would be an advantage.