Validation Specialist/ Pharmaceutical
Salary: £35,000 - £40,000 DOE
Our Client, a well known pharmaceutical manufacturer is growing and looking to bring in an experienced Validation Specialist who will play a key role in some of the new equipment qualification, process validation and analytical method validation plans/ implementation.
- Execute Equipment Qualification activities in line with Annex 15. Prepare associated documentation, ensuring these are approved as per project timelines and site procedures.
- Execute Process Validation activities such as writing of Process Validation Plans, Protocols and reports.
- Using recognized statistical techniques for process validation to demonstrate process control and process capability
- Execute Cleaning Validation activities such as calculation of MACO values and writing of associated documentation, ensure these are approved as per project timelines and site procedures.
- Liaise across departments and communicate new validation requirements as the facility continues to grow
- Ensure Process/Equipment Validation activities are executed in line with business requirements, including the supervision of vendors or contracted staff where applicable.
- Comply with company Policies, Standard Operating Procedures (SOP's), and GMP at all times, maintaining inspection readiness.
- Conducting service works directly relating to Environmental Monitoring, Validation and Temperature Mapping.
- Complete PQS documentation such as change control, CAPA and deviations relating to validation activities
- Management and control of service equipment ensuring equipment is maintained, checked and returned.
- Completing on-site system commissioning & training
- Prioritisation of time management to ensure deliverables are achieved in a timely manner.
- Providing on site customer support, technical advice and troubleshooting where necessary.
- Preparation and execution of paperwork for service and calibration works.
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
- Relevant degree in a Scientific or Engineering discipline
- Proven industry experience working as a Validation Specialist / Process-equipment Validation Specialist / Process Engineer / Quality Validation Engineer
- Proven industry experience having completed equipment qualifications, test method validations and Cleaning validations.
- Experience of applying statistical techniques to validation activities