Quality Assurance Validation (QAV) Executive - Cell Therapy

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Job Description

Quality Assurance Validation (QAV) Executive– Cell Therapy

REPORTS TO: Head of Quality Assurance, Cell Therapy

JOB PURPOSE:

The Quality Validation Executive is responsible for ensure quality oversight on validation ensuring compliance with current industry regulations, guidelines and trends. The Quality Validation Executive will have specific and varying responsibilities as assigned by the Head of Quality Assurance, Cell Therapy. Tasks are outlined below.

Quality Assurance Validation Executive Responsibilities

• Provide quality assurance validation support and approval (pre/post/approval) for qualification/validation lifecycle documents
• Support Aseptic Processing Simulations(APS) with regard to APS strategy, the generation of protocol, report and real-time review APS during execution.
• Provide Quality expertise Supporting the Qualification of premises, equipment and utilities;
• Include aseptic processing systems oversight (APS, VHP validation, Environmental Monitoring)
• Computer system qualification.
• Laboratory equipment validation.
• Process validation.
• Perform quality assurance assessments relating to validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities and requalification activities .
• Responsible, with management support, for providing oversight of quality activities associated with the Quality records, MES, LIMS, SOPs.
• This main role must ensure interaction the Operations, Engineering and CQV functions together with major such as Artwork, Supply Chain, QC, IT, QPs to ensure the reliable delivery of quality, safe, product to patients.
• Provide validation position on related topics and strategy and prioritise qualification activities following the project schedules.
• Be Quality subject matter expert for in process validation which will be performed against global corporate SOP/HPRA /FDA/EMEA requirements.
• Ensure GMP compliance for validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers) including requirements definition, specification, qualification, process validation and change management.
• Provide Quality support for the development (or modification phases) of manufacturing facility, equipment/systems, Material Qualification, Process Validation and Automated System and Computerised System.
• Approve and help define the process development strategies and ensure linkage with PPQ strategy deployment.
• Provide support during internal and agency inspections, Annual Product Quality Review and performing quality assessment for engineering changes.
• Participate in other projects as directed by the Head of Quality Assurance.

GENERAL RESPONSIBILITIES:

• Guide and promote the corporate values of Takeda-ism within the workplace.
• Foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an necessary part of the business.
• Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
• Ensure completion of all SOP, reading, training and assessment.
• Other responsibilities and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:

• Bachelor's degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
• Experience working in regulated environment with exposure in regulations and guidance's – GMP, CGMP, GAMP, 21 CFR Part 11.
• 3 years of experience in commissioning, qualification, and validation activities in a regulated environment.
• Technical knowledge of validation/ verification, quality systems and regulatory requirements.

RELEVANT EXPERIENCE:

• A minimum of 7 years working within quality in the pharmaceutical industry.
• A minimum of 4 years validation experience.
• 3 + years of experience in QA technical role.
• Experience of sterile/biologics manufacture is essential.
• Good knowledge of relevant computer packages e.g. Trackwise, SAP, Tracelink and documentation systems.
• Experience working with ATMP is desirable.

SKILLS/COMPETENCIES:

• Knowledge of Good Manufacturing Practice for Advanced Therapeutic Medical Product (ATMP).
• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
• Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements

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