6-month contract role.
Hybrid, 3 days onsite in Dublin and 2 days remote.
The QE is responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC/Cluster (including controlled substance requirements and all named-patient materials NPP). He/she is also responsible for compliance with the elements of the company Quality Policy and company QMS that are applicable to the GMP/GDP activities the LOC/Cluster undertakes. This position is also responsible for the continuous improvement of the GMP/GDP status of the LOC/Cluster. He/she is responsible for the oversight of quality and compliance status of all third parties and other company organisations engaged by the LOC/Cluster for the GMP/GDP activities for the LOC/Cluster.
Key Role Activities
Implement, maintain and monitor the GMP/GDP part of the company quality system for the commercial organisation in the LOC (to include but not restricted to):
- Ensure that a list of all relevant product sourcing, supply routes (including exports), product licences (marketing authorizations), product list, relevant authorizations, (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.) and quality agreements is available and maintained up to date for the Irish market.
- Execute requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity. Including the preparation, update and approval of procedures assigned.
- Ensure the provision of appropriate training for all regulated functions with GMP/GDP responsibilities.
- Ensure appropriate management of internal and external Change Controls related to the Irish market.
- Oversee the preparation, execution and follow up for corporate and external Irish inspections, and report these and any other relevant field action activity into the relevant systems.
- Ensure appropriate management of the preparation, execution and follow up of internal and external Quality Issues (QIs) and CAPAs related to GxP in Ireland.
- Monitor Quality System performance versus local GxP and company requirements via use of pertinent business and compliance metrics and goals.
Quality processes (to include but not restricted to):
- Conduct regular (self-)inspections of GxP practices that are applicable on the supply chain within the responsibilities of the Local Operating Company.
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, Deliver QA, ASM, Regulatory Affairs, Medical Affairs, Medical Compliance, other Cluster / LOC in EMEA and any other functions.
- Ensure GxP Irish suppliers in the LOC/Cluster are qualified, are periodically audited against company & local GxP standards, if relevant and, when needed, have a quality agreement. Timely preparation of quality agreements. Perform supplier audits as required.
- Support the LOC management team in new product introduction in Ireland and all other product portfolio lifecycle management processes.
- Perform Product Quality Reviews for products marketed in Ireland, reviewing local PQRs.
- Ensure that any requirements of the Wholesale Dealers Licence are fulfilled.
- Perform the QA approval of repackaging jobs of Irish products and ensure that all required aspects of GMP are followed at both the repackaging site and within the company for these jobs.
Essential Technical Knowledge, skills and experience
- Quality Assurance experience at operational level or other relevant experience including Quality Compliance.
- Direct experience and sound knowledge of general quality requirements and guidelines/legislation.
- Leadership and Teamworking capabilities
- The QE should meet the following knowledge, experience and skills:
- Primary level 8 degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline.
- At least 2 years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management.
- Manufacturing / QA operations experience is essential.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.