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.
QA Manufacturing Manager is required for a purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
Reporting directly to the QA Director of Grifols Worldwide Operations (GWWO).
The position will be responsible for a team of QA Manufacturing Specialists, Technicians and Supervisors.
To complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the aseptic manufacturing operations in Grifols Worldwide Operations Ltd (GWWO).
KEY RESPONSIBILITIES: Ensure regular Quality interaction with other Departments including Validation, Manufacturing, Quality Control and Maintenance and represent QA Manufacturing as Risk Champion. Interact with licence holder to ensure all product licence requirements are maintained and any deviations/change controls are assessed appropriately against licence requirements. Interact with sister sites for harmonisation activities as part of working groups/continuous improvement initiatives. QA Activities for Manufacturing Site including Environmental monitoring, deviation impact assessment, change control impact assessment, investigation oversight and CAPA implementation. Lead Environmental monitoring review committee and address all observations and trends as required. Reviewing and approving SOP's, validation protocols/reports, batch records and other GMP documentation. Establish KPIs for the QA Manufacturing Group. Maintain a high level of technical writing expertise and stay current with regulatory trends. Ensure compliance with company quality requirements and customer quality requirements. Ensure continuous audit readiness and cGMP compliance. Participate and lead risk assessments to support contamination control strategy and ensure compliance with Annex 1. Support the annual product quality reviews if required. Represent Quality in related improvement projects. Provide Quality support for aseptic manufacturing operations and GMP implementation at GWWO. Oversight of Albumin Manufacturing Processes to ensure audit readiness for the manufacturing facility. Perform Walkthrough Audits and self-inspections of the facility. Training of new Quality personnel where appropriate and development of new training. Build organizational competency and succession plans. Involvement in interviewing/selection process of hiring or promoting department personnel. Conduct performance reviews of personnel. Act as delegate for activities performed by the Quality Assurance Director. Perform other duties as required by Management. PERSON SPECIFICATION Extensive knowledge and understanding of EU GMP Annex 1 and aseptic regulatory requirements. Extensive microbial knowledge and contamination controls for aseptic manufacturing. Interpret and apply applicable 21CFRPart11, USP, EP and ICH regulatory guidelines and directives. Strong communication and interpersonal skills with ability to interact with all levels of personnel in a professional manner. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. Strong organizational, analytical and problem-solving skills.
Ability to analyze details and perform structured decision-making. Demonstrated leadership skills with ability to motivate, guide, train and develop. Competence in Microsoft packages specifically Word, Excel and PowerPoint. Self-starter and flexible. Results oriented. Minimum 5 years experience in aseptic pharmaceutical industry. Minimum of B.Sc Degree/MSc in Microbiology/Biochemistry/Biotechnology or related discipline. Experience in statistical analysis including use of Minitab. General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control. Experience leading and facilitating Quality Risk Management. QP eligible or QP experience in aseptic manufacturing. 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. Wellness activities - Social activities e.g.
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.
Location: EMEA : Ireland : Dublin Grange Castle (Dublin)
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