QA Team Lead - Shop Floor, Environmental Monitoring

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