Aseptic Lead

at  Grifols Worldwide Op Ltd

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.

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.

• 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 e.g. 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.