Aseptic Lead

2 weeks ago

Dublin, Dublin City, Ireland Grifols Full time

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  

Perform as a knowledgeable subject matter expert (SME) for the filling aseptic operations. Provide cross-functional development and technical expertise to the filling operations team in the aseptic Filling department in the Albumin plant. Develop supervisors to become subject matter experts in aseptic techniques and behaviours and continue to provide technical support. Provide input and expertise on sterile standards, guidelines in Annex 1 2023, Annex 15, and EU GMP Guide. Ensure that objectives are effectively achieved, consistent with our company requirements, to ensure compliance, safety and reliability.  Create, revise and monitor training plans for aseptic filling techniques, behaviours and monitor the progress of each team member.  Support/Coach team members training/development needs and ensure all receive appropriate training and qualification. Develop and maintain training programs focusing on sterile standards, guidelines and regulations. Review of aseptic filling documentation (SOP's, OJT's, etc) for area to ensure they are current, accurate, and clear.  Be effectively involved in (process simulation) media fills. Liase with Quality, Validation and operations team to ensure the successful completion of (process simulation) media fills. Support investigations that impact on safety, quality and/or compliance of the processes, ensure investigations are carried out and actionable CAPAs are implemented within agreed timelines. Hands on training of new and current team members while ensuring they are competent and qualified to perform their duties.  Keep up to date with industry trends via conference . HPRA, FDA and attend when required. Support a safe working environment by complying with all pertinent environmental health and safety practices, rules, and regulations.  Generating reports and presentations as required. Have a clear understanding of what is happening in the assigned area of responsibility.  Lead and/or support personnel environmental monitoring plan and execution for the filling departments work stream. Monitor any trends in personnel and environmental monitoring, identify actions that will enable the process and the Manufacturing areas better achieve compliance. Provide an environment that allows for continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process. Provide ongoing formal and informal feedback on the Aseptic qualification of the operations team.  Responsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day-to-day activities and all applicable job functions. Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations. Lead audit readiness in the area, Ensuring the facility and equipment is maintained to the highest standards for regulatory and corporate inspections. The role will also lead other aspects of operations if the business need arises.

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

There will be time spent at a desk while writing documentation. The time spent at the desk can vary during a shift depending on the schedule during the shift. It could be for up to a full shift depending on the amount of documentation accumulated during training and monitoring.

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 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

#LI-FD1

Location: Grange Castle (Dublin)  

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