Validation Engineer (closed)
Our Multinational Healthcare Client has a requirement for a Validation Engineer
- 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.
- 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.