Batch Release Specialist
- Dublin, Ireland
Site Name: Ireland - Dublin
Posted Date: Feb 4 2021
We are currently hiring for Two Batch Release Specialist to be based in our Dublin office.
These are Permanent positions.
The Batch Release Specialist prepares product release dossiers for presentation to the EU / UK QP Hub QPs. This involves reviewing batch deviations, transit temperature control devices, sampling plan and test results. It includes following up with the manufacturing sites and Logistics groups on issues that arise from the reviews to support batch certification processes.
The scope of this role includes support to GSK Trading Services, GSK Export Ltd, Consumer Trading Services and ViiV Trading Services, and may be expanded to support other entities if created. The EU / UK QP Hub manages approximately 1000 batches per annum and this role is key to ensuring compliant release of batches.
As Batch Release Specialist, you will be responsible for:
- Liaise with Principal Trading Companies (PTC) and other groups for co-ordination of batch release scheduling for products imported into Europe
- Prepare batch release dossiers for presentation to the QP in support of compliant batch release and timely escalation of any issues identified
- Review associated records and documentation, including deviations and liaise with the manufacturing site and QP to understand the impact of the deviation on product quality prior to release - manage correspondence and communication between the parties to conclusion.
- Raise and track iCargo deviations for transit temperature excursions, liaising with the Pharma Logistics group and supplying sites to resolve and close, ensuring escalation to the QPs.
- Raise and investigate deviations relating to importation activities
- Conduct activities to support EU / UK QP Hub processes related to quality oversight for importation, including;
- Quality meetings
- Deviation investigation and reporting
- Key performance indicators generation and reporting
- SOP / Technical report preparation and approval
- Conduct/participate in audits / self-inspections
- Periodic Product Reviews
- Liaise with importation warehouse and import testing laboratories to ensure sample delivery, receive testing data and work with laboratory to resolve any issues related to testing of imported products.
- Ensure records of batches certified are maintained, and dossiers and samples archived in accordance with local SOPs and GMP requirements.
- Effectively communicate with Supply Chain Hubs, Local Operating Companies, manufacturing sites, External Supply managers and importation warehouse and provide feedback to all on progress of release as required
- Present data on GSK's behalf during regulatory inspections of importation operations.
- Third Level Degree in a Science related subject.
- Experienced in manufacturing site operations, batch record review, quality data review and operational quality requirements
- Understanding of quality management principles and documentation requirements for GMP compliance
- Capable of working in multi-disciplinary teams across IT, Quality, External Supply, Global Logistics, Supply Chain and Manufacturing
- Working knowledge of GMP and GDP regulations
- Able to present on aspects of the certification process where role holder has responsibility during regulatory inspections
- Experienced in application of GPS thinking and tools and knowledge of performance measures
Why work at GSK?
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
Are you ready to take the next step in your career? We will shortly be holding interviews for the role so apply today!
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).
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