Would you like to join an international team working to improve the future of healthcare?
Do you want to enhance the lives of millions of people?
Grifols is a global healthcare company that since **** has been working to improve the health and well-being of people around the world.
We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture.
We are committed to equal employment opportunities that foster an inclusive environment.
Position Summary
The Technical Lead for Validation will represent the Validation team in leading validation projects and driving strategic initiatives.
This role is responsible for planning and implementing validation strategies for major capital projects and serving as the primary Validation representative in technical forums, including internal and external audits.
What you'll do
Write, review and execute Validation Protocols and Reports for Equipment, Steam sterilisation, Utilities, Processes, Cleaning and Equipment Software ensuring compliance to all relevant global and local quality and validation procedures/standards
Review change controls and assess impact of changes that affect validated systems and define validation requirements
Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA
Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures
Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc.) to ensure equipment meets current GMP requirements and industry standards
Maintain the Site Validation Master Plan (VMP) and associated Project VMPs, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
Execute/Co-ordinate Re-Validation activities as required
Completion of risk assessments, closure of corrective and preventive actions and deviations
Develop alternative solutions to problems, handles Highly complexity problems independently.
Demonstrates technical knowledge and ability to adapt to changing circumstances.
Works with other departments Operations, Quality, and Maintenance to lead qualification and validation efforts in support of site projects
Performs other validation associated activities as defined by Manager or Director
Evaluate and analyse validation data collected during projects, verify adequacy of the information and compliance with regulations.
Performs reviewed activities in protocols.
May have signature authority for Validation Manager with appropriate qualification
What you'll bring
QualificationsProject Management Experience
Hands-on knowledge of execution of Validation
Experience in a Quality or Validation Role within Pharma sector
Experience with Software validation for manufacturing
Experience in Cleaning, Process and Aseptic Process Validation
Excellent Technical Writing and analytical skills
Familiarity with cGMPs and industry and federal guidelines required
Experience with Word, Excel and Access computer applications
Strong interpersonal skills for interactions with other departments
Degree in Science/Engineering and/or Min 5 years Validation experience
Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
Familiarity with ISO-***** (Cleanrooms and Associated Environments)
Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
Experience within aseptic manufacturing environment
Benefits
Highly competitive salary
Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Wellness activities - Social activities eg.
Padel, Summer Events
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