Siobhan Stackpoole Email & Phone Number

Shannon, County Clare, Ireland

Performs environmental monitoring of the MeiraGTx aseptic manufacturing facility.Ensures all testing is completed as per Environmental Monitoring programme.Adheres to aseptic technique when working in controlled facilities as wel as QC laboratories.Performs analysis of the environmental monitoring samples.Updates EM results database.Records and reports out of specification results and implements corrective actions as applicable.Maintains QC facilities to meet GMP requirements, conducts necessary checks to support any health authority, customer/stakeholders site visits.Ensure the laboratory paperwork and operations are fuly GMP compliant.Performs QC testing of materials and products as required.Operates and maintains laboratory equipment, ensuring all equipment is calibrated and suitable for use asHandles or disposes of hazardous materials safely and in accordance with procedures.Supports maintaining the Quality Management System and control of documents, ensuring the data integrity of all data produced.Supports with all reasonable managerial requests and ad-hoc tasks.Works closely and collaboratively with the Manufacturing, Engineering, QA and Supply Chain teams.Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice(GDP) and is undertaken in accordance with applicable procedures.Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs &audit/inspection actions are closed timely and in a RFT state.

Performing routine and non-routine analysis, as requested by management and leads or customer representative.Completion of training records and ensuring all records presented for review and approval are at the appropriate standard.Ensuring at all times that all documentation and laboratory records are up to date and of an appropriate standard. Development of documentation (SOPs, protocols etc) in collaboration with the customer.Ensuring that all work carried out is approached “Right First Time” so as to avoid and re-work or errors. Gain a clear understanding of all related customer supplemental processes such as deviation handling, training documentation, document and records control.Performing second person verification checks.Revising SOPs and updating other documentation as required by group lead.Ensuring uniformity, reproducibility and reliability in all work practices.Identifying any opportunities for improvement of quality and service and work with the team to implement continuous improvement. Participating in team meetings and giving updates to rest of team as necessary.Ensuring all decisions are handled with customer service in mind. Assisting in laboratory investigations as appropriate.Ensuring that all documentation is completed on time. Ensuring that it is accurate and legible and conforms to the relevant quality standards.

Limerick, County Limerick, Ireland

Responsible for the management of samples associated with the PSS analytical Team.Responsible for carrying out water sampling in grey space sampling areas.Responsible for accurately logging samples into the relevant systems in a timely manner as required.Responsible for ensuring all relevant documentation is completed accurately and logged where necessary.Responsible for cleaning laboratory areas and equipment as required e.g. BSC’s, fridges, Incubators, etc.Assisting laboratory analytical personnel and perform ad-hoc lab duties as required.Providing training to other team members as instructed by the PSS Manager/Group Leader.Ensuring at all times that all documentation and laboratory records are up to date and of an appropriate standard.Being constantly aware of customer’s requirements and striving to meet or exceed those requirements keeping in mind the customer process end points.Dealing with customer queries and to contact designated personnel with any relevant information or issues relating to test results or the service in general.Keeping the work area clean and tidy in both seen and unseen areasIdentifying any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

County Cork, Ireland

Attention to detail demonstrated through precision of conducting experiments in the lab.Responsible for ensuring raw material providers had the correct credentials in the incidence of an audit. Also responsible for updating system containing the credentials.Collaborated with other members of staff in advising on new essential maintenance routines and updating current routines around the entire plant.Responsible for grading final products. This involved reviewing lab results and client specifications to ensure they met quality and client standards.Investigation and reporting on Customer Complaints and Material ReturnsBuilt and maintained strong professional relationships with both clients and colleagues.

County Limerick, Ireland