QA Team Lead – Shop Floor, Environmental Monitoring

Grifols; Dublin; In loco; EUR 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

Jobtailor in Ireland seeks a QA/QA Compliance Lead to ensure aseptic manufacturing quality and cGMP adherence, guiding a team of QA professionals across environmental monitoring, deviations, CAPAs, and documentation.

You will drive training, support batch release readiness, and collaborate with manufacturing, QA, and regulatory bodies to sustain high standards and continuous improvement in a fast-paced facility.

Competenze

• Experience in sterile GMP environments with QA function.
• Experience with QMS processes (paper and electronic).
• Experience in Grade A-D cleanrooms with RABS.
• Experience with deviations, investigations, and CAPAs.
• Strong problem-solving mindset and leadership abilities.
• Excellent verbal and written communication in English.
• Proven project management skills for multiple high-priority tasks.
• Solid understanding of EU GMP Annex 1 and ICH Q9/Q10 quality risk management.

Mansioni

• Lead QA activities ensuring aseptic manufacture compliance.
• Oversee deviations, investigations, CAPAs, and batch records.
• Manage documentation review and approvals (MBRs, SOPs, Training).
• Mentor and coach team members; promote training and development.
• Collaborate with Manufacturing, QA, and regulatory bodies to ensure compliance.

Conoscenze

Quality management

GMP compliance

Regulatory knowledge

Team leadership

Problem solving

English proficiency

Project management

Attention to detail

Formazione

Pharmaceutical degree

Bachelor's degree in Science

Strumenti

Veeva Vault

Trackwise

SAP

LIMS

Descrizione del lavoro

• 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 policy
• Provide the team’s 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 function’s goals and objectives, aligned with the departmental strategic objectives
• Support the team’s 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 applicable, 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
• Provide operational leadership to navigate the teams, inclusive of Analysts and Specialists, including coaching, mentoring, performance management, professional development, and objective setting
• Manage the team’s 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
• 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

Requirements

• 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