Qc

YOUR MISSION To manage incoming materials and support Good Manufacturing Practice (GMP) compliant activities for the QC release of product and incoming materials.  Support QC Materials Team in other activities where requested. JOB DESCRIPTION MAJOR ACTIVITIES * Perform inspection of incoming materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product. * Monitor the material inspection programme ensuring materials are suitable for the manufacture of gene therapy products to the required standards. * Physical inspection of raw materials. Ensure the warehouse storage environment is acceptable for the materials being inspected (Can be multiple warehouse locations). * Coordinate incoming material testing where required. * Maintain all incoming material documentation meets GMP requirements. * Ensure adequate control of the material status for release or Reject. * Comply with MeiraGTx procedures including Health and safety and GMP. * To ensure all equipment used is calibrated/maintained and in line with SOP’s. * Identify and report procedural problems and deviations. * Perform and support environmental monitoring activities for the sampling room, in line with GMP requirements, ensuring results are recorded and reported. * Perform sampling of incoming raw materials, following SOPs and GMP practices to ensure seamless supply of material to support aseptic manufacture of ATMP product. * Participate in the planning of duties to ensure the facility is acceptable and customers receive products on time and in full. * Any other duties/projects within the skills and ability of the post holder. * Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. * Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. * Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state. KEY PERFORMANCE INDICATORS * HR process compliance. * Material release KPIs. * GMP compliance. * Data integrity.   KEY JOB COMPETENCIES * Experience of working within a GMP manufacturing environment. * Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. * A high Level of attention to detail. * Problem Solving - Identifies and resolves problems in a timely manner; able to gather information; develops alternative solutions; works well in group problem solving situations. * Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. * Planning/Organizing - prioritizes and plans work activities; uses time efficiently. * Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. * Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas. * Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings. * Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. * Physical & mental requirements - occasional lifting; the noise level in the work environment is usually moderate.   JOB RESPONSIBILITIES * Compliance with GMP.   JOB BACKGROUND * Minimum 1 years experience working in a GxP environment. * Experience of quality documentation. * Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.

About Inizio Ignite: Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Company Descriptor Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health. Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. About the team: We have recently established a new Scripting Team in India, based in Gurgaon. This hub is part of the global Operations team and sits within the Data Management & Dashboard Delivery (DMD) capability. The team supports ad hoc, tracking and syndicated quantitative studies as the business transitions from an outsourced vendor model to a stronger blended / in-house delivery model. The team scripts and maintains online questionnaires for healthcare professionals, patients and other key stakeholders. By integrating complex logic, customized routing, validation checks and robust testing, the team ensures high-quality data capture and supports downstream data processing, analytics, dashboarding, reporting and insight generation. As the team scales, the priority is to strengthen scripting quality, technical governance, capability-building and readiness for more complex programming requirements. Your primary role: The Scripting Senior Manager - SME is a senior Subject Matter Expert role within the Scripting department, reporting to the Associate Director, Data Management & Dashboard Delivery (DMD). The role provides the highest level of in-house scripting expertise for India DMD and acts as the technical authority, escalation point and quality owner for complex survey programming. This role is critical to scaling the scripting function and de-risking the transition from outsourced delivery to a blended / in-house model. It combines hands-on complex scripting with technical governance, quality ownership, team coaching, process development, capability-building and stakeholder advisory. The successful candidate will help build confidence that the India team can deliver increasingly complex scripting requirements to the required quality standard while reducing dependency on external vendors. This will include: * Acting as the senior technical SME for the Scripting department, providing expert oversight across complex online survey programming, advanced logic, routing, validation, quotas and respondent experience. * Providing hands-on scripting and programming of high-complexity online surveys using the Confirmit platform, including custom logic, advanced routing, validations, quality controls and troubleshooting. * Exploring emerging survey technology, AI-enabled research tools and automation opportunities, with the ability to assess which solutions can practically improve scripting quality, speed and scalability. * Acting as the escalation point for complex scripting issues, technical risks and quality concerns across ad hoc, tracking, Pathfinder, Ignite, syndicated and other quantitative study types. * Providing upfront technical review of complex questionnaires to identify scripting risks, confirm feasibility and recommend efficient survey design solutions * Supporting the transition from an outsourced model to a blended / in-house model by assessing scripting complexity, identifying readiness gaps, highlighting capability or resourcing risks and capturing lessons learned as work moves in-house. * Building and delivering an upskilling plan for the scripting team, with particular focus on complex programming requirements such as conjoint exercises, segmentations, advanced routing, trackers and syndicated study complexity. * Providing technical guidance, mentoring and quality feedback to Scripting Senior Managers, Managers and Executives; line management may be included where required as the team scales. * Partnering closely with Research, Project Management, Data Processing, Dashboarding and Analytics teams to ensure scripting design supports accurate downstream data flow, tabulation, dashboarding and reporting. * Advising internal stakeholders on scripting best practice, feasibility, risks, options and solutions, translating technical considerations clearly for non-technical audiences. Your skills and experience: * More than 11 years of experience in a senior scripting role within a market research agency, with evidence of operating at SME / technical lead level; healthcare / life sciences market research experience is strongly preferred. * Deep proficiency in Confirmit's scripting platform, including authoring, complex logic implementation, deployment, testing, troubleshooting and quality control. * Strong practical knowledge of JavaScript, HTML and CSS for customizing survey functionality, layout and respondent experience. * Experience using AI or automation tools to improve survey scripting, QC, documentation, code review or workflow efficiency. * Proven experience scripting complex quantitative research studies, ideally including trackers, syndicated studies, conjoint exercises, segmentations, complex routing, quotas and validation requirements. * Strong understanding of quantitative research methodologies, questionnaire structures, healthcare market research standards and the downstream implications of scripting decisions for data processing, analytics, dashboarding and reporting. * Experience establishing, maturing or improving an in-house scripting function, ideally including process design, quality frameworks, documentation, training plans and transition from outsourced delivery. * Demonstrable experience mentoring, coaching and developing scripting team members, including quality feedback, capability-building and support for complex technical problem solving. * Strong analytical judgement, problem-solving ability and the confidence to identify, escalate and resolve quality, feasibility or delivery risks. * Excellent communication skills, with the ability to explain technical issues, options and implications to non-technical stakeholders in an international environment. Ideal profile: * You are a hands-on technical expert who can operate as the senior SME, quality owner, escalation point, coach and trusted advisor to senior stakeholders. * You are comfortable sitting above the standard Senior Manager role, providing expert challenge, guidance and technical assurance without losing the ability to get hands-on when needed. * You are proactive, dedicated and enthusiastic, with a can-do attitude and a strong ownership mindset. * You demonstrate a high level of accuracy and attention to detail, as well as strong organisation and prioritization skills. * You are comfortable working in a scaling team where processes are still being built and where ambiguity needs to be turned into clear ways of working. * You are collaborative and able to build effective relationships across Research, Project Management, DMD, Data Processing, Dashboarding, Analytics and UK stakeholder groups. * You communicate ideas, risks and issues in a clear, practical and solution-focused way. * You are motivated by the opportunity to build a new scripting capability, strengthen in-house delivery and develop others. * Experience developing reusable scripting templates, code libraries, macros, checklists, QC frameworks or automation tools that reduce manual effort and improve the TAT Life at Research Partnership: We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide: - A comprehensive training and development programme for all staff, from entry level apprentice to senior management. - Opportunities for international travel and collaboration. - A relaxed and friendly working environment.   Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.