Overview
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.
Responsibilities
Write, review and execute Validation Protocols and Reports for Equipment Qualification, Aseptic Process Validation, Cleaning Validation, Process Validation, Temperature Mapping (steam sterilisation) and Equipment Software Validation, ensuring compliance to all relevant global and local quality and validation procedures/standards
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
Development and execution of Process Validation protocols and reports (Cleaning Validation, APS, Process Validation and Continuous Process Verification)
Demonstrates technical knowledge and ability to adapt to changing circumstances.
Works with other departments Operations, Quality, and Maintenance to execute qualification and validation efforts in support of site projects
Completion of risk assessments, closure of corrective and preventive actions (CAPAs)
Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements
Performs other validation associated activities as defined by Manager or Director
Key Competencies
Temperature Mapping (steam sterilisation)
Cleaning Validation
Process Validation
Aseptic Process Validation
Temperature Mapping (steam sterilisation), preferable
Commissioning and Qualification
Documentation (Writing SOPs, Protocols, Reports)
Auditing
Strong communication / presentation skills during internal/external audits
Person Specification
Qualifications
Project Management Experience
Hands-on knowledge of execution of Validation (Min 2 years)
Experience in a Quality or Validation Role within Pharma sector
Experience within aseptic manufacturing environment
Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
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 2 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)
Experience with Software validation for manufacturing
Benefits
Highly competitive salary
Group pension scheme - Contribution rates up to 7%
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Education allowance
Wellness activities - Social activities eg.
Golf, Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities.
We encourage everyone who meets the qualifications to apply – we're excited to hear from you.
Location:
Grange Castle International Business Park, Grange, Clondalkin, Co.
Dublin, D22 K2R3
Learn more about Grifols
Req ID:
Type:
Regular Full-Time
Job Category:
#J-*****-Ljbffr