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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 successful candidate will be a key contributor to a dynamic and highly technical team and will be required to build collaborations with Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control and Global Regulatory groups. The position is accountable for the timely completion of Utilities, Facilities, and equipment qualification related milestones, PPQ, process monitoring and manufacturing support.
What You'll Do:
Define, execute, and report qualification, re-qualification, and validation studies in order to establish and maintain the qualified/validated status of range of status of facilities, utilities, and equipment in accordance with internal procedures, regulatory requirements, and industry guidance/standards.
Provide technical expertise for investigation and compliant resolution of non-conformances encountered during requalification, revalidation, and periodic review activities (with support from senior validation team members).
Advise systems owner and vendors on suitability and required standards/functionality of new systems during the selection process.
Strong knowledge of cGMP compliance, site and regulatory agency requirements and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
Participates in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics
Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
Create and update Validation Master Plan (VMP), defining the approach defining the validation approach associated with each system, process and the requalification requirements including study requirements and frequency.
Completion of risk assessments, and closure of corrective and preventive actions and deviations.
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.
The role will require strong interaction with QA. This role involves building effective working relationships with other functional organizations, such as Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, Regulatory, and others, both internally and externally to the site.
What You'll Bring:
Education and Experience
BSc, MSc, or PhD, in a relevant discipline (e.g., biochemistry, chemistry, pharmaceutical science, biology, engineering) or equivalent experience.
3+ year's experience in pharmaceutical manufacturing organization and/or bioprocess development, with experience in facilities, utilities and equipment validation.
Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
Project management capability.
Ability to work effectively as part of a team across all departments.
Knowledge of quality systems, Quality by Design, validation principles for equipment, utility, and facility.
Technical Skill Requirement
Be proficient in SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint desirable.
Strong strategic and analytical thinking, problem solving and rapid decision-making skills.
Demonstrated capability in implementing challenging goals, objectives, and practices in a complex and ambiguous/matrix environment.
Understanding of project management systems and tools. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
Experience in qualification of, utilities, facilities, and processing equipment.
Our Benefits Include:
Highly competitive salary
Annual performance based bonus %
Shares options scheme
Group pension scheme - Contribution rates are (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
Education allowance
Wellness activities - Social activities eg. 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
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Location: Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3
Learn more about Grifols
