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Role Summary: The Lead QA Specialist/Senior OP is responsible for managing and drive the site QA systems in conjunction with other Specialists in the QA Product Quality team.
The successful candidate will be responsible for coordinating all QA duties relating to QP batch release and communicate all issues relating to batch release schedule in a timely manner to schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines. To proactively identify and implement industry best practices including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance.
Responsible for coordination of the certification of finished product batches to the market as required under the EU Directive 2001/83/EC
• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization • Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff • Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required • Pro actively participate in the QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required • Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective • Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract labs • Coordinate and provide QP support to QA colleagues with product quality / license impact assessment for deviations • Ensure Quality Managers are appraised on all Quality related issues • Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business • Responsible for driving the Quality goals in conjunction with the QA Management team in support of the overall business objectives • Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice Functional departments in the organisation • Excellent communication and negotiation skills promoting openness, dialogue and collaboration • Results orientated with a strong ability to effectively troubleshoot and problem solve issues • Exceptional planning skills to consistently deliver stretch targets and objectives • Act as a change agent to promote a culture of continuous improvement • Role model the GE Beliefs
• Proven Years’ experience within a regulated environment. • 3rd level qualification in Science / Engineering discipline or equivalent knowledge & experience • Eligibility to act as a Qualified Person in line with local and EU directives • Self-starter with good motivational, decision making, planning, project management and communication skills. • Good level of knowledge of Quality, safety regulations, manufacturing and process automation. • Excellent interpersonal skills with the ability to work effectively with staff at all levels across multiple functions of the organization. • Experience in developing strong working relationships across teams and functions.
• Some years of supervisory/management experience is preferred. • Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. • Demonstrated collaboration, negotiation & conflict resolution skills • Excellent communication skills (written and oral) • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance • Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment. • Demonstrated understanding of continuous quality / process improvement tools: • (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S) • Experience leading and implementing change • Experience performing internal audits and participating in external audits • Exceptional analytical, problem solving & root-cause analysis skills • Ability to multi-task & handle tasks with competing priorities effectively • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
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