Overview
Process Validation Specialist Jobs in County Waterford, Ireland at Elusav Recruitment
Title: Process Validation Specialist
Company: Elusav Recruitment
Location: County Waterford, Ireland
Elusav Recruitment have an amazing opportunity for a Process Validation Specialist with a leading global biopharma company in Waterford, Ireland.
As the Process Validation Specialist, you will be required to support new product introductions, equipment qualification and the site requalification program.
Responsibilities:
Designing, executing and reporting on PV/Process Performance Qualifications. Designing, executing and reporting on PV/Process Performance Qualifications.
Designing, executing and reporting on validation studies for equipment, systems and processes.
Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times.
Maintaining validation documentation through the validation lifecycle.
Participation in external regulatory inspections.
Support Site Change Control process.
Requirements:
3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec).
Capable of troubleshooting validation issues associated with projects, process development etc. Capable of troubleshooting validation issues associated with projects, process development etc.
Competent technical knowledge of pharmaceutical plants.
Previous validation/product development experience would be highly advantageous for the role.
Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
Knowledge of requirements for of GAMP, ISPE Baseline guides.
Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
Full understanding of relevant quality and compliance regulations.
Able to execute projects to plan.
Good knowledge of quality management systems.
Good communication skills at organisation, team and individual levels.
Ability to use MS Project and SPC packages an advantage.
Understands KPI’s for the site.
Contact:
If you would like to learn more about the vacancy, apply now, or contact Stephen O’Brien on [email protected] or +3536959993.
