ROLE – QA & QC : This position has a strong bias for action and results-oriented strategic and tactical behavior. The ability to manage multiple, complex projects and work effectively in a global environment is required. Overall responsible for Plant Quality control and Quality assurance activities of Biotech Europe Meditech Inc. Ltd., Roscommon, Ireland. Responsible for quality assurance activity for upcoming new projects in Ireland.Employee is expected to support the quality concepts inherent in the business philosophies of Biotech Europe Meditech Inc Ltd, including a variety of job-related tasks which may not be specific to this position profile.RESPONSIBILITIES:QUALITY CONTROL AND ASSURANCE IN BIOTECH EUROPE MEDITECH INCResponsible for designing, updating, approving, and implementing QMS SOPs.Review, approve, and implement validation documentation, SMF, VMP, QM, and other apex documents.Ensure periodic self-inspections/internal audits and MRM.Oversee and approve NCR, customer complaints, CAPA, and change control, deviation ensuring continued compliance.Organize product recall if required per procedure.Ensure environmental monitoring and testing is carried out to GMP in line with documented procedure.Perform transactions in Trackwise and DMS system (QMS system) for NCR, customer complaints, CCN, or any deviation.Ensure that new electronic software for different purposes is evaluated and implemented at the site.Ensure all validation and calibration activities are carried out as per yearly plan.Ensure vendor audits are carried out as per SOP.Manage the QMS system as per USFDA requirements for the site.Conduct internal calls with the customer for USFDA compliance and for any new requirements.Ensure stability testing is carried out as per plan and records are maintained.Ensure that all appropriate suppliers are evaluated and listed on the approved vendor list.Approve RM/PM/FP and stability specifications and method of analysis.Review batch records and release the batch as per requirement.Oversee document management process including change control process, document distribution, retrieval, and archive.Perform gap analysis of site for regulatory/statutory compliance as per required standard.Any other responsibilities assigned by HOD and management.
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