QA Team Lead Shop Floor & Environmental Monitoring (EM)

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.

POSITION SUMMARY

QA Team Lead Shop Floor & Environmental Monitoring (EM) is responsible for providing leadership and management to two distinctive QA operational functions Shop Floor and Environmental Monitoring.

This position will focus on the quality compliance and EM data generation aspects of Albumin Manufacturing both purification/formulation and aseptically filled product ensuring that operations are performed in accordance to the defined procedures maintaining GxP standards to provide assurance of product quality and patient safety. Specifically the Team Lead will be responsible for the teams day-to-day manufacturing operations and general business requirements. Additionally have responsibility of the teams structure and professional development with coaching mentoring and acting as a subject expert to support.

The QA Shop Floor and EM functions are an on-the-ground stakeholder of all core manufacturing departments including the wider QA network manufacturing maintenance automation and supporting functions.

Understanding of industry compliance guidances notably EU GMP Annex 1 Sterile Manufacturing with general knowledge of the ICH Q-series PDA ISO and the FDA Aseptic Guide as well as a working understanding of aseptic manufacturing controls within a Grade A-D environment will be essential to be successful in this role.

What Youll Do:

• Ensure the quality of the work is maintained and inspection-ready in accordance with internal and external cGxP requirements and expectation.
• Ensure adherence to GMP EU Annex 1 FDA and other applicable regulatory guidelines.
• Support the cross-function readiness for batch certification ensuring all documentation related to the team is finalised within a timely manner.
• Ensure the team is in compliance with all Training and Health & Safety requirements in accordance with company the teams performance status with regular interaction with cross-functional peers and management as defined via tier/triage-structures.
• Support the success of inter-team and cross-team KPIs to ensure performance is measurable for the functions goals and objectives aligned with the departmental strategic objectives.
• Support the teams organisational structuring and provide general direction to ensure the team is successful in handling day-to-day operations.
• Ensure the team is adequately trained to cover the full scope of responsibilities and develop training (internal and external) where appliable to ensure quality and technical competencies.
• Be the functions voice / point-of-contact for the teams to ensure appropriate distribution of communication (given & received).
• Support resource management (capacity model & hiring process) to aid departmental objectives and business requirements.
• Deputise for cross-shift peer Team Leads and/or the Supervisor as required.

Leadership and Managerial:

• Provide operational leadership to navigate the teams inclusive of Analysts and Specialists including coaching mentoring performance management professional development and objective setting.
• Manage the teams routine activities ensuring they are scheduled performed and completed within agreed timeframes and in accordance with procedures and regulations. Activities are inclusive of:
  
  

QA Shop Floor:

• Leading the Quality Culture to the manufacturing operation through on-the-job coaching and mentoring in aseptic manufacturing inclusive of adhering to aseptic principles behaviours and overall aseptic manufacturing controls in-situ (e.g. Gowning Disinfection).
• Performing daily GEMBAs and facility walk-through audits of the manufacturing areas from Grade A critical interventions to Grade B C and D supporting activities.
• Support the decision-making process in atypical event handling on the floor inclusive of aseptic intervention and maintenance activities.
• Support the manufacturing in-process control (IPC) and end-of-batch reconciliation processes ensuring the manufacturing operation is compliant to the defined batch records and procedures.
• Support air visualization studies (smoke studies) and aseptic process simulations to develop and maintain aseptic principles and behaviours.
• Supporting the deviation investigation CAPA and change lifecycle in collaboration with the wider QA functions.
• Authoring reviewing and approving documentation inclusive of MBRs Risk Assessments SOPs and Training as required.
• KPI monitoring specifically focused on personnel aseptic behaviours Grade A & B qualifications and deviations associated to lapses in the defined contamination controls.

QA Environmental Monitoring:

• Performing viable total particulate (non-viable) water systems and gas monitoring throughout Grade A B C and D classified areas.
• Supporting the deviation investigation and CAPA lifecycle including impact analysis and overall quality robustness and effectiveness associated to Environmental Monitoring excursions.
• Authoring reviewing and approving documentation inclusive of Risk Assessments SOPs Training and Records as required.
• Support environmental data analysis to generate periodic trending reports for overall facility evaluation and impact.
• Support the overall contamination control strategy from an EM perspective including sampling methodologies and techniques.
• Foster a strong stakeholder collaboration with other core QA and MFG functions to ensure quality compliance standards are adhered to.
• Foster a LEAN attitude to create a pro-active continuous improvement culture within the team and support the facilitation of Quality Mindset throughout.
• Provide feedback to the team to facilitate professional development and foster an open-door culture.
• Any other duties as required following consultation with the post holder.

Technical:

• Provide technical expertise predominantly focused on regulations for aseptic manufacture and environmental monitoring execution presented in the form of coaching mentoring and presentations for stakeholder understanding.
• Participate in risk assessments or strategic decision meetings and act as an SME to ensure either new or modified processes are appropriately implemented for operational success under cGMP conditions.

What Youll Bring:

• Working experience within a Sterile Pharmaceutical GMP-regulated industry with a Quality function.
• Working experience with QMS processes both paper-based and electronic systems (e.g. Veeva Vault Trackwise etc.)
• Working experience within Grade A B C and D cleanroom environments and associated controls in-situ utilizing RABS technology.
• Working experience with deviations Investigations and CAPAs.
• Demonstrate a problem-solving mindset and working ethic/culture to effectively lead the team.
• Excellent verbal and written communication in English.
• Proficiency in Microsoft software.
• Working experience of people management of 2 persons.
• Demonstrate project management skillsets for effective handling of multiple high-priority tasks.
• Sound understanding of EU GMP aseptic manufacture notably Annex 1 Sterile Manufacture.
• Understanding of ICH Q9 and Q10 Quality Risk Management.
• Understanding and experience with an EU regulatory body with hands-on inspection experience.
• Understanding of Albumin manufacture Purification and Aseptic Filling in a bag presentation.
• Exposure to systems such as SAP KNEAT and LIMS.
• Strong organisational and coordination ability
• High attention to detail and accuracy under pressure
• Ability to multitask and manage shifting priorities effectively
• Proactive and solution-oriented mindset
• Discretion reliability and professionalism in handling sensitive matters
• Strong interpersonal skills for cross-functional collaboration
• Ability to work independently with minimal supervision

Our Benefits Include:

• Highly competitive salary
• Annual performance based bonus %
• Shares options scheme
• Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
• 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. 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 were excited to hear from you

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Location: Grange Castle International Business Park Grange Clondalkin Co. Dublin D22 K2R3

Learn more about Grifols

Employment Type : Full-Time
Experience: years
Vacancy: 1