A leading diagnostics manufacturer requires a Validation Specialist to join its team. Your role will be to co-ordinate and execute the validation and re-qualification of facilities, processes, equipment, and Computer Systems. You must have proven experience in a previous validation position. You must have experience or understanding of GMP.
To co-ordinate and execute the validation and re-qualification of facilities, processes, equipment, and Computer Systems (including cleaning validation) where required, to meet the Kent Operations business needs.
May include some or all of the following:
- Ensure review and update of validation procedures (Policies, Master plans, SOP's etc.) for equipment and facilities
- Establish and maintain Validation Plans as applicable
- To prepare, execute and report validation protocol including cleaning validation in accordance with EU GMP
- To perform qualification and requalification temperature mapping activities of storage locations, i.e. refrigerators, freezers and incubators
- To perform qualification studies on other equipment and processes
- Establish and maintain the re-qualification schedule for validated equipment
- Liaise with Engineering, Quality Assurance and User Departments to ensure that validation is conducted in a timely manner according to the Validation Plan and with minimal disruption to production
- Attend meetings, both internal and external, representing the department in a professional manner
- Participate in audits by customers and regulatory authorities
- To ensure that safe working methods and practices are adopted at all times and in accordance with Company policy for the safety of the postholder and others within the working environment.
- To be responsible for housekeeping, tidiness and general cleanliness of all areas in which the post holder is working.
- Degree level, preferably in Chemistry, Biology, Engineering or a Related Subjects
- Knowledge of cGMP
- Understanding of ISO 9001 and ISO13485 Quality Systems
- General understanding of IQ, OQ, PQ, PV
- Temperature mapping
- Cleaning Validation
- Data Integrity
- Water system validation
- HVAC system validation
- Temperature mapping
- Ability to author and execute validation reports
- Ability to write validation related procedures
- Understanding of calibration principles
- Ability to challenge systems to ensure that they are slick and value adding as well as being compliant
- Use of Microsoft Word, PowerPoint and Excel
- It is important that the post holder is self motivated and can manage multiple tasks. The role carries a high degree of responsibility and has a critical impact on the operation of cGMP related processes.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6919
- Posted: 18th May 2021
- Expires: 15th June 2021