Senior Quality Assurance Associate
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.
- Direct Reports: Manage/ supervise members of the QA team as set by the QMS Lead
- 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