Current Openings

Senior Quality Assurance Associate

London

DEPARTMENT: QUALITY ASSURANCE

LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – QMS LEAD

Purpose of Job

Ensuring QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner. Supervise, manage and train the QA team and continuously improve the local Quality system and provide training & support for Quality relevant systems. Set QA objectives for the QA team. Support the QMS Lead in other activities where requested.

Major Activities and Responsibilities:

  • Management of the MeiraGTx Quality Management System
  • Generation, Review and approval of relevant GMP documentation.
  • Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
  • Maintain QA KPI metrics.
  • Collaborate with Operational areas, proactively manage the day to day QA Operations.
  • Review Batch documentation and manage 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 and Change Controls.
  • Provide QA review for the eQMS system.
  • Create and review Risk reporting and Mitigation.
  • 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.

Key Job Competencies

  • Experience of working within a GMP manufacturing environment.
  • Understanding controlled processes.
  • Proficient in Microsoft Office and experience in database use and eQMS systems.
  • Excellent interpersonal skills
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability.
  • Able to prioritise workload, decisive thinker able to work within agreed timescales.
  • A high Level of attention to detail.
  • Knowledge of GCP and GMP with regards to QMS activities
  • Good team player and must also be able to work alone.
  • Experience in Competent authority, Regulatory body inspections and audits.

Job Responsibilities

  • Direct Reports: Manage/ supervise members of the QA team as set by the QMS Lead

Job Background

  • Experience working in a GxP 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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