This person will bring current understanding of wet processing to enable the design of the new facility. As Validation Specialist you will be the primary validation representative responsible for the project. You will be trusted to lead and advise the validation of new facility, utilities, equipment and processes as part of the project team - and you will do it via a constructive dialogue founded within a pragmatic understanding of the business' needs.
- Lead the Qualification and Validation support on the Wet Processing Project team to ensure compliance with the requirements of Code of Federal Regulations 21 CFR Parts 210, 211 and Part 11, EudraLex Rules Governing Medicinal Products in the European Community Volume 4 and Annex 1-18, ICH Q7A and Company policies and procedures.
- To lead the validation of new facility, utilities, equipment and processes and liaise with the project team on qualification & validation scheduling and reports to ensure a good design basis is established for all validation studies.
- Preparation, and reviews of VMP/DQ/FQ/IQ/OQ/PQ/PV/CV protocols/reports and associated deviations for equipment, facility, utility, process & computerised systems.
- Preparation and reviews of FAT/FS/URS/SDS/HDS documents and reports to ensure a good design basis is established for all validations
- Implementation of Cleaning Validation program for the project
- Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
- 5 years' experience working with validation and qualification projects in the pharma industry.
- Experience in relevant regulatory requirements
- Experience working across a Global business a distinct advantage
- Skilled in the execution of Risk Assessment and in the use of a variety of problem solving techniques
- Experience in projects, audits & inspections as Validation SME
- LEAN and Six Sigma philosophy are embedded in your day to day working
- Enjoy working closely with your stakeholders and have a hands-on operational approach to Validation
- A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude
- Work independently with strong personal drive
- Strong attention to detail and organisational skills
- Have the ability to critically assess issues and devise and execute appropriate solutions using problem solving techniques in a decisive manner
- Strong business mindset
- Travel may be required as part of the role to represent Global Quality on elements of project implementation.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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