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.
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 QA Validation Lead is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in GWWO. Technical expertise in biopharmaceutical manufacturing is required to provide support to Commercial and Clinical manufacturing operations as well as Process Development operations. This position requires a detailed knowledge and understanding of product-contacting materials, technologies, applications, and suppliers. Knowledge of industry standards that govern chemical raw materials (USP, compendia, etc.) and understanding of Annex 1 and aseptic regulatory requirements is essential.
KEY RESPONSIBILITIES:
* Act as a representative for the Quality team in the absence of the quality supervisor/manager
* Provide material and supplier qualification information as required
* Ensure regular Quality interaction with other Departments
* Design and develop policies for validation and ensure compliance with regulatory requirements
* Lead all aspects of QA validation including reviewing and approving documents such as Failure investigations, Change controls, SOPs, Validation protocols and summary reports, Validation Master Plans
* Manage QA Validation Department personnel by assisting in developing validation work plans, establishing objectives, and assigning tasks
* Develop and manage QA validation budget, contracts, and schedules
* Present and defend data to HPRA, FDA and other regulatory agencies
* Maintain QA validation document and software control system
* Ensure efficient collaboration with the Validation department to maintain validation status for equipment and software in commercial and clinical manufacturing
* Organize QA validation resources to meet goals and timings; coordinate and prioritize activities with area management
* Develop and apply new approaches and processes to validation strategies
* Support and assist in developing a broad-based validation program with senior managers and executives
* Support employees' work performance; conduct hiring and discharge interviews
* Create projects, spreadsheets, and presentations using Microsoft Office programs
* Continue education on understanding of new technologies and regulations
PERSON SPECIFICATION:
* Strong technical writing skills
* Competence in Microsoft packages specifically Word, Excel, and PowerPoint
* Good organizational skills
* Flexibility
* Results oriented
* Ability to make decisions
* Ability to handle multiple projects and deadlines
* Deep knowledge of aseptic regulatory requirements
* Minimum of B.Sc Degree in Life Sciences, Chemistry or Engineering with at least 5 years' experience in a quality or production function within the biological/aseptic pharmaceutical industry
* Technical expertise in biopharmaceutical manufacturing
* Experience in a project/start-up environment
Our Benefits Include:
* 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 e.g., 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, Co. Dublin, D22 K2R3
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