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Open nowPosted 5 days ago

Senior QA Associate

meiragtx7 open roles

Where
London
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Your applicationOpen nowSenior QA Associatemeiragtx · London

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  2. 3.6%3 days
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  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 5 days ago

The posting

Your mission

  • Provide experienced QA support and oversight to MeiraGTx operations.
  • Ensure QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.
  • Coach and train the QA team and other functions and continuously improve the local Quality system and provide training & support for Quality relevant systems.

Job Description

Major Activities and Responsibilities:

  • Provide QA oversight to the manufacturing operation and supporting functions.
  • Management of the MeiraGTx Quality Management System.
  • Generation, Review and approval of relevant GMP documentation.
  • Create and Review QA Processes. Create/review Standard Operating Procedures, Policies and Training material.
  • Maintain QA KPI metrics.
  • Collaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations.
  • Review Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
  • Manage and support QA team Facility Walk rounds and QA support for all operational areas.
  • Provide direct quality team support during customer and regulatory audits.
  • Perform internal audits and inspections and audit write up.
  • Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality Risk Assessments, Incidents, Deviations, CAPA’s, OOS, Change Controls and temperature excursions.
  • Support Document Management activities when required.
  • Proactively initiate and support continuous improvement of the Quality Management System.
  • Deliver compliance training to operational areas.
  • Provide guidance and assistance to quality related issues in Operational areas and to External third parties.
  • Deputise for the QA Team Leader – Operations when required.
  • Proactive individual, able to step in without being asked. Identifies upcoming activities or tasks and works on completion without the need to be asked.
  • Collaboration and stakeholder management.
  • Adaptability ad resilience.
  • Supports innovation by challenging outdated practices and encouraging better ways of working.
  • Always asks and understands the “why” and is capable of explaining this to others. Does not automatically accept the status quo.
  • Finds better ways for completing existing activities/processes saving time or effort while remaining compliant.
  • Data driven decision making. Able to check reliability of sources, identify gaps, inconsistencies or misleading information.
  • Demonstrates critical thinking and logical reasoning.

Key Job Competencies and Behaviours

  • Minimum 5 years experience of working within a sterile GMP manufacturing environment.
  • Excellent understanding of Quality Management Systems.
  • Demonstrate very good understanding of the purpose of the regulation requirements in terms of how they translate to product quality and patient safety.
  • Proficient in Microsoft Office and experience in database use and eQMS systems.
  • Excellent interpersonal skills. Role model for professional behaviours, respectful relationships, positive and constructive communication.
  • Capable of demonstrating structured thinking, data gathering and analysis for informed decisions.
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability. Capable of consistent on-time delivery of their individual tasks and responsibilities. Able to prioritise workload, decisive thinker able to work within agreed timescales.
  • A high level of attention to detail.
  • Good team player and must also be able to work independently.
  • Strong experience in Regulatory inspections and Client audits.

Job Background

  • Experience working in a Sterile manufacturing GMP environment including a minimum 5 years’ experience in Compliance and Quality Assurance.
  • IT literate, experience managing and operating an electronic QMS.
  • Excellent verbal and written communication skills.
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