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 1909 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.
POSITION SUMMARY:
Represent the Validation team as a Technical Lead and Lead position for Validation projects. You will plan and implement Validation strategies for major capital projects and represent Validation at technical forums including external and internal audits. You'll write, review and execute Validation Plans, Protocols, and Reports for the new GWWO ensuring compliance with all relevant global and local quality and validation procedures/standards. Initial requirements will focus on the areas of Equipment, Utilities, CSV, and Cleanroom Validation.
KEY RESPONSIBILITIES:
* Write, review, and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping, and Equipment Software) ensuring compliance with all relevant global and local quality and validation procedures/standards.
* Review change controls and assess the 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.
* Generate and review project documentation (User Requirement Specifications, validation protocols, reports, etc.) and Standard Operating Procedures.
* Support validation activities including the 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/Coordinate Re-Validation activities as required.
* Complete risk assessments and close corrective and preventive actions.
* Investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements.
* Perform other validation-associated activities as defined by the Manager or Director.
KEY COMPETENCIES
* Packaging Equipment
* Computer System Validation
* Clean Utilities
* Calibration
* Autoclave / Thermal Mapping
* Process and Cleaning Validation
* Commissioning and Qualification
* Documentation (Writing SOPs, Protocols, Reports)
* Clean Room Qualification
* Auditing
PERSON SPECIFICATION
* Project Management Experience
* Hands-on knowledge of execution of Validation
* Experience in a Quality or Validation Role within the Pharma sector
* Experience with Software validation for manufacturing
* 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 4 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-14644 (Cleanrooms and Associated Environments)
* Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
* Experience within an aseptic manufacturing environment
Our Benefits Include:
* Highly competitive salary
* Group pension scheme - Contribution rates are 5% employer and 5% employee
* 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 e.g. Padel, Summer Event
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.
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