Your mission
Purpose of Job
Providing ongoing QA support pertaining to the validation requirements for all GxP processes, analytical methods, equipment, facilities, and computerized systems across MeiraGTx sites.
Remain up to date and act as a subject matter expert in relation to applicable EU and FDA regulations, ensuring that MeiraGTx validation policies and procedures remain compliant and best practice.
Ensure that all validation and technology transfer documentation is subject to QA review in a timely manner and in line with regulatory and business requirements.
Support QMS activities such as review of deviation investigations and impact assessment of change controls, where validation and computerized systems expertise is required
Job Description
Major Activities
- Adequately provide QA support and oversight to activities related to validation, computerised systems, and technology transfer activities, ensuring compliance with EU, UK and FDA GxP regulatory requirements, MeiraGTx QMS and any other applicable regulations/standards.
- Maintaining an understanding of cGMP, GEP (Good Engineering Practice), computerised systems validation, and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
- Ensure the timely review of qualification protocols, discrepancies, and associated reports in a timely manner reporting any concerns to the QA Management.
- Act as QA reviewer/ approver for MeiraGTx Policies, SOPs, work instructions and forms that govern the MeiraGTx validation and computerised systems requirements.
- Develop and, where appropriate, deliver GxP training across the business regarding GxP, in particular in relation to validation and qualification (including computerised systems validation and data integrity).
- Interface with other departments such as Engineering, Laboratories, Operations, Warehouse, IT, and Process Development to ensure that validation project plans are understood and in keeping with site objectives.
- Represents the company as an SME for Validation and Tech Transfer compliance during regulatory inspections and partner audits, inclusive of support for the compilation of any required responses and other follow-up activities.
- Support the execution of the site self-inspection and supplier audit programme where required when validation activities are within scope.
- Lead problem solving and remediation requirements for operational compliance systems.
- Ensure area of responsibility is inspection ready and kept in compliance.
- Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls & audit/inspection actions, within own area of responsibility, are closed within date and in a ‘Right First Time’ state.
- Ensure own training is undertaken in a timely and compliant manner before any associated tasks are undertaken.
- Ensure that own work complies with GMP, Data Integrity & Good Documentation Practice (GDocP) and is undertaken in accordance with MeiraGTx’s QMS.
Key Performance Indicators
- In conjunction with the Validation function ensuring that company validation procedures are ‘fit for purpose’ and in line with regaulatory requirements.
- Ensure that all GxP equipment, facilities, processes and analytical methods are appropriately qualified, and that they aere maintained in such a state throughout their lifecycle, informing QA Senior Management of any concerns in a timely manner.
- Own responsibilities are performed in a timely manner, escalating any and all issues to QA Validation Manager as and when they occur.
Key Job Competencies
- Experience in communicating with regulators during health authority inspections is desirable.
- Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
- Approachable and professional manner, reacting well under pressure, accepting feedback and managing opinions of others
- Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate
- Ability to dissect problems and solutions to provide a variety of unique options in a comprehensive manner
- Effectively manage changes in accordance with change control processes.
- Logical, problem-solving manner, able to adapt to change
Job Background
- Educated to degree level in Human Health, Sciences or equivalent
- Minimum of 5 years experience working in a GxP environment, predominantly with regards to the execution or review of validation and computerised systems documentation
- Excellent practical Knowledge of GxP regulations and guidelines with regards to validation and qualification
- English language required
Why us?