LSC have a great contract opportunity for a Validation Specialist to join a leading Pharmaceutical company based in Cork.
If you have 5 years’ experience working with validation and qualification projects in the pharma industry and are ready for your next challege, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Lead the Qualification and Validation support on Wet Processing project team to ensure compliance with the requirements of 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.
o To lead the validation of new facility, utilities, equipment and processes and liaise with project team on qualification & validation scheduling and reports to ensure a good design basis is established for all validation studies.
o Preparation, and reviews of VMP/DQ/FQ/IQ/OQ/PQ/PV/CV protocols/reports and associated deviations for equipment, facility, utility, process & computerised systems.
o Preparation and reviews of FAT/FS/URS/SDS/HDS documents and reports to ensure a good design basis is established for all validations
o Implementation of Cleaning Validation program for the project
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Minimum qualification of a Bachelor Degree in a scientific/technical discipline required
o 5 years’ experience working with validation and qualification projects in the pharma industry.
o Experience in relevant regulatory requirements
o Experience working across a Global business a distinct advantage
o Skilled in the execution of Risk Assessment and in the use of a variety of problem solving techniques
o Experience in projects, audits & inspections as Validation SME
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
If you would like to hear more about this Validation Specialist role, then please contact Kathy at LSC on 021-4777329 or apply directly through this advert.