QA SPECIALIST required ASAP for pharmaceutical client in Dublin, 6 month contract with hybrid working arrangement, i.e. 3 days onsite in Dublin...so Dublin based candidates with EU citizenship OR relevant Visa / Stamp will only be considered.
The QA SPECIALIST will have a minumum of 3-5 years' experience in pharmaceuticals preferably experience in GDP (Good Distribution Products and familiarity with the IPHA code). They will be 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).
Role of this position
- 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 J&J requirements via use of pertinent business and compliance metrics and goals.
- Provide the necessary input to the Quality Head for the bi-annual Quality System Management Review for the LOC/Cluster. Co-ordinate the timely preparation of the QSMR presentation i.e. slide deck by gathering input from all SMEs and stakeholders.
- Notify and engage LOC Quality Head and Business Quality Regional and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures. The QE supports the local Quality Head for escalations of the LOC/Cluster where needed.
- External Body Qualification/Certification as Internal Auditor is preferred title
- 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
- Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
- At least 2 (ideally 5) years' experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), 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;
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)