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QA Team Lead - Shop Floor, Environmental Monitoring

Posted 2 days 12 hours ago by Jobtailor

Permanent

Full Time

Retail & Consumer Products Jobs

Dublin, Ireland

Job Description

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