Job Title: Quality Assurance Specialist
This role plays a pivotal part in ensuring the quality management system is functioning optimally, and regulatory requirements are met.
The position requires strong technical knowledge, particularly of cGxP requirements and regulations. It also demands adaptability, multi-tasking abilities, and the capacity to handle tasks with competing priorities effectively.
* In this position, you will be responsible for supporting the qualification of new material suppliers and GMP service providers and maintaining their lists.
* You will participate in auditing these suppliers and service providers from time to time.
* Additionally, you will act as a key user for material supplier data on SAP.
* You will also support the review and approval of changes made by these suppliers and service providers, including coordinating change control activities with internal and external cross-functional teams.
* Your responsibilities will include supporting the resolution of quality deviations and closure of CAPAs.
* You will be involved in the internal audit program, including managing the schedule, conducting audits, and reporting metrics related to internal audits.
* You will participate in audits and/or inspections carried out at the site by regulatory authorities or clients.
* You will contribute to initiatives and action plans aimed at improving QA and enhancing GMP compliance.
* You will manage and provide support for the site's electronic quality management system (EQMS).
* You will provide site metrics and KPIs as required for the Quality Management System (QMS).
* You will provide support for the Quality Management Review (QMR) as applicable.
* You will review and approve risk assessments, change controls, deviations, and complaint investigations, and collate PQRs.
* You will support the site's regulatory surveillance.
* You will manage product & material complaints.
* You will execute mock recalls.
* You will assist in preparation and presentation of GMP orientation and refresher training programs.
Required skills and qualifications:
* A Bachelor's degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage.
* Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
* Experience in the biotechnology and/or pharmaceutical industry within a Quality role.
* Strong technical aptitude.
* Strong knowledge of cGxP requirements and regulations.
* Adaptable.
* Able to multi-task and handle tasks with competing priorities effectively.
We offer a competitive salary, bonus scheme, parking, pension, and VHI benefits. Must be willing to travel if/when required.