Your mission
Undertake the duties and responsibilities of the Qualified Person as defined in the Human Medicines Regulations 2012:1916 and Clinical Trial Regulations 2004:1031.
Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management System.
Ensure systems are identified and in place to maintain compliance with current established GxP standards.
Support senior QA leadership through QP decision making to drive continuous to drive continuous improvement and compliance.
Job Description
Major Activities:
- Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF as applicable.
- Review completed batch records and complete batch dispositions
- Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations from Manufacturing, Tech. Transfer through Warehouse activities, Engineering, Quality Control, Supply Chain and Operations support
- Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency
- Work as part of the MeiraGTx team to undertake continuous improvement of business quality systems
- Act as Quality liaison for external client on commercial program.
- Attend and participate in the Quality Management Review meetings.
- Ensure that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner.
- Advise and participate in projects from a quality assurance perspective.
- Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes.
- Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits.
- Performs external audits as required.
- Help with the development of QA personnel, including trainee QPs as required.
- Develop and deliver training related to the QMS and any other role related training as required
- Reinforce GMP on site providing training and coaching where appropriate; promote a ‘Quality Mindset’ with peers and stakeholders.
- 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 Job Competencies:
- Excellent interpersonal skills
- Extensive knowledge and understanding of pharmaceutical Quality Assurance and GMP experience within an operations environment. This knowledge must be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product for clinical and commercial use
- Extensive knowledge and proven track record of improving Quality Management Systems which are simple, robust and in compliance with applicable cGxP regulations and guidelines
- Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
- Knowledge of preparing for, hosting and follow up on regulatory inspections
- Flexibility to meet changing needs and priorities of the business
- Must have a hands on approach, and experience with facilitating a Quality Culture and building a "Quality Mindset" for team members who has limited experience or not worked within a GxP environment
Job Background: - Eligibility to act as a 'Qualified Person' as defined in Human Medicines Regulations 2012:1916 and Clinical Trial Regulation 2004:1031 is essential
- Strong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations
- Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals
- Strong interpersonal skills; must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
Why us?