Overview
Do you have a degree in Engineering/Science or extensive experience working in a Validation role within the Pharmaceutical/healthcare industry? We are looking for a Validation Officer to join our Aseptic Services team to support with planning, executing and maintaining validation activities. The role is 37.5 hours per week Monday-Friday, 7.5 hours between the hours of 8am - 6pm and it will be based in Runcorn.
Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients.
Responsibilities
1. Draft, review and improve validation documentation
2. Execute all validation activities relating to facilities, processes, cleaning, and equipment, ensuring that all validation is performed in compliance to cGxp
3. Planning and scheduling validation activities to maintain validation status
4. Maintain compliance with Data Integrity Regulations and GAMP standards
5. Investigate the root cause(s) of non-conformances and identify and ensure implementation of corrective / preventive actions to reduce non-conformances
6. Support manufacturing and other operations in the development, implementation and maintenance of GxP standards
7. Provide technical support to production to maintain GxP and production efficiency
8. Complete risk assessments as required to ensure that the production equipment and production facilities comply with the relevant GxP and HSE guidelines
9. Collate, review and interpret data from the QMS process
10. Perform trend analysis of data and generate trend analysis reports and implement effective corrective measures as required
11. Maintain an awareness of developments in the field of validation to ensure a continued provision of an up-to-date service, providing guidance and training
12. Occasionally work outside of hours
Qualifications
13. Minimum of a Degree in engineering/science subject or extensive experience of working in a validation role within the pharmaceutical/healthcare related industry
14. Experience and knowledge of cGMP and regulatory requirements for areas of expertise
15. Experience of manufacture of sterile medicinal products
16. Experience in thermal mapping and small instrument/systems (balances, pumps) is an advantage
17. Clean room experience at least to Grade C is an advantage
Benefits
18. No rota'd weekend working and no night shifts
19. Contributory Pension Scheme (rises with service)
20. Role specific tailored training and development plan
21. Life Insurance (4 x salary, death in service)
22. 25 days holiday (rises to 35 after 5 years service) and ability to buy/sell holidays
23. Healthcare cashback scheme (including dental, optical & alternative therapies)
24. Maternity, Paternity and Adoption Leave
25. Professional fees paid
26. Bike to work scheme
27. Long Service Awards
28. Employee Assistance Programme
29. Free onsite parking and subsidised canteen
30. Blue Light Card
31. Company funded family days out
We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.