Aseptic Lead
4 months ago
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.
The Aseptic Lead will be responsible for coaching, mentoring and training of the operations team on primary aseptic manufacturing, clean room behaviours, aseptic behaviours and techniques while supporting Aseptic Excellence and Sterility Assurance in the filling area. The Aseptic Operations Lead will report directly to the Aseptic Filling Manager in the Albumin Plant.
KEY RESPONSIBILITIES
PERSON SPECIFICATION
Strong Knowledge of Sterile Manufacturing Processes Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of EudraLex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products and Eu GMP guide. Knowledge of Filling and Aseptic Practices, sterilization, GMP regulations and Quality operations Strong knowledge of Environmental, Monitoring, personnel monitoring and contamination control Demonstrated leadership skills with ability to motivate, guide, train, coach and develop teams. Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas. Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators Facility Start up experience an advantage. Willing to travel domestically and internationally if/as required.Gowning
Gowning from one grade to another there are benches that need to be stepped over has to be performed unaided with no support rail. When placing arms inside the sleeves need to be standing again unaided. Bending forward you then need the cover all over the head and body with gowns. Bending forward again zips in between both legs need to be zipped. Stand unaided or raise one leg to place boots on. Once inside the area for the role you will need to be standing for up to 4 hours a time to monitor and train technicians.
Documentation
Qualifications
Previous Pharmaceutical/ Bioscience experience Bachelor’s degree in microbiology or related discipline. 5+ year's operations experience in a sterile manufacturing environment. Hands on knowledge developing and maintaining training programmes. Ability to motivate, guide, train, coach and develop team members. Proactive and works well with others in a collaborative, fast-paced goal-driven environment. Proven ability to work in a high paced organization and effectively reach targets and goals. Excellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the aseptic filling area. Excellent verbal and written communication skills, Strong Technical writing skills. Train the trainer qualified.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 Education allowance Wellness activities - Social activities eg. Golf, Padel, Summer EventsWe 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
#LI-FD1
Location: Grange Castle (Dublin)
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