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.
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
Reporting to the Manufacturing Filling Manager, the Manufacturing Filling Supervisor is responsible for the start-up, development, and execution of the manufacturing specific requirements from a project-based environment through to commercial readiness and supervision thereafter. The Supervisor will work across functions to achieve objectives including, but not limited to, Quality, Supply Chain, Manufacturing, Validation, Engineering and H&S ensuring that products meet or exceed all safety, quality, customer service and cost targets.
KEY RESPONSIBILITIES
1. Plan, organize, and execute the manufacturing department start up and the commercial manufacturing plan. Support process development, documentation, qualification, and validation from the initial project phase right through to the commercial manufacturing phase.
2. Assure the appropriate interaction with support groups such as Quality, Technology, Engineering & Maintenance, Supply Chain, Regulatory Affairs, EHS and Human Relations.
3. Responsible to ensure that the aseptic products are produced in a timely and safe manner which meet or exceed all specifications, quality standards, HPRA & FDA regulations, and other Health Authority guidelines.
4. Ensures the use of qualified personnel on all validated and calibrated equipment and processes.
5. Monitor, record, display and drive Key Performance Indicators for the Department, including but not limited to; Overall Equipment Effectiveness (OEE), production yields report, resources and facilities utilization reports.
6. Support quality investigations and contribute to CAPA reporting.
7. Act as a cross functional partner to identify and prioritize continuous improvement opportunities to improve the quality, safety, reliability, RFT and productivity of the manufacturing and testing processes.
8. Selects and maintains qualified personnel in all positions, assists in career planning and conducts performance reviews.
9. Communicates regularly with employees and management about department performance, plans and initiatives.
10. Develop and maintain a training curriculum for staff ensuring that ‘standard work’ practices are employed.
11. Safety and Environmental officer for the area responsible for audit preparation for the area, monitoring and communication of incident and accident trends.
12. Ensure supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance, monitoring absenteeism and managing holiday requests.
13. Review and complete all Company documentation in line with cGMP requirements
14. Performs other duties as assigned, in any area of Grifols Worldwide Operations, as defined by business needs
PERSON SPECIFICATION
15. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
16. Must be proactive, results oriented, and have strong attention to detail.
17. Self-starter with strong work ethic and the ability to exercise good judgment.
18. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
19. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
20. Promote a culture of continuous improvement using Operation Excellence tools and methodology.
21. Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly desired
22. Must be available to work shift as directed by the organization.
23. Excellent verbal and written communication skills in the English language.
24. Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
25. Bachelor's degree: Emphasis on Biology, Chemistry, Manufacturing or Mechanical Engineering or closely related scientific / technical discipline essential.
26. Candidates must have a minimum of 2 years of related experience leading and managing people in a pharmaceutical, GMP, or EU regulated environment.
27. Facility Start up experience an advantage.
28. Willing to travel domestically and internationally if/as required.
29. Train the Trainer qualified
Our Benefits Include:
30. Highly competitive salary
31. Group pension scheme - Contribution rates are 5% employer and 5% employee
32. Private Medical Insurance for the employee
33. Ongoing opportunities for career development in a rapidly expanding work environment
34. Succession planning and internal promotions
35. Education allowance
36. 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 (Dublin)