Validation Specialist - Pharma / Biopharma - Permanent - South East
Our client is a leading life science organisation. At present, they are seeking a Validation Specialist on a permanent basis at their site in the South East, UK.
Responsibilities:
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 site operations business needs.
Deliverables:
- 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.
Education / Experience:
- Degree level, preferably in Chemistry, Biology, Engineering or a Related Subjects
- Knowledge of cGMP
- Understanding of ISO 9001 and ISO13485 Quality Systems
Key Skills:
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.
Training:
- Understanding of ISO 9001 and ISO 13485 Quality System
- Knowledge of cGMP