QC Specialist - Npi

Pe Global

Dublin

PE Global is currently recruiting for QC Specialist – NPI for a Client site in Dublin: Primary Responsibilities, Accountabilities and Decisions Rights. QC Representative for site / laboratory upgrade projects. Plan and manage QC related activities from site projects. QC Representative for NPI activities and routine Product meetings. Plan and Perform non-core testing related to NPI activities. Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities. Create/own and approve protocols, sample plans, SOP and documentation related to NPI. Responsible for their own training and safety compliance. Assist with resource management, QC Project Management and other work streams as required by the lab management. Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports. Job Summary: Under minimal direction, functions as the specialist for non- core project team (NPI) functions and is responsible for one or more of the following activities in QC including analytical testing, characterization, sample, data management, equipment qualification and Project management. Contributes to team by ensuring the quality of the tasks/services provided by self. Contributes to the completion of milestones associated with specific projects or activities within team. This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required. Specific Job Duties: With a high degree of technical flexibility, work across diverse areas within QC. Plan and perform analyses with great efficiency and accuracy. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. May train others as necessary. Participate in audits, initiatives and projects that may be departmental or organizational in scope. Write protocols and perform assay validation and equipment qualification/ verification. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. May contribute to regulatory filings. May conduct lab investigations as necessary. Evaluate lab practices for compliance on a continuous basis. Approve lab results. May represent the department/organization on various teams. May interact with outside resources. Create APPX data files and randomisation memo to facilitate data analysis. LIMS data coordination of commercial and import testing on site where applicable. May provide technical guidance. May contribute to regulatory filings. May represent the department/organization on various teams. May train others. May interact with outside resources. Primary knowledge, skills, competencies and relevant experience. Knowledge & Experience: Broad technical knowledge within QC. Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization. Enhances own knowledge through understanding business trends and objectives. Knowledge of industry and business principles. Understands the core business process and purpose of the functional area in clientss commercialization process. Familiarity with change management approaches, tools, and methodology. Strong facilitation skills and presentation skills. Ability to work and collaborate with various levels within the organization and influence cross functionally. Routine resource management, QC Project Management and other work streams as required by the lab. Developing, maintaining, tracking, and managing high quality, integrated plans to enable accurate reporting and decision making to reflect the immediate and long-term needs of each project. Problem Solving : Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information. Qualitative information. Quantitative research. Trend data. Forecasts, models, and utilizes advanced analytical tools. Anticipates and prevents potential problems. Creates new procedures and processes to drive desired results. Handles diverse scope of issues that require evaluation of a variety of factors including current business trends. Autonomy: Works under minimal direction. Work is guided by operational and project objectives. Manages multiple assignments and processes. Independently determines approach to project. May be responsible for specific programs and/or projects. Independently develops solutions that are thorough, practical, and consistent with functional objectives. Contribution: Contributes to work group/team by ensuring quality of tasks/services provided by self and others. Provides training and guidance to others. Extends capabilities by working closely with senior staff/experts within and outside the internal organization. Skills: Take initiative to identify and drive improvements. Communication skills (verbal and written) at all levels. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls. Presentation skills. Escalate issues professionally and on a timely basis. Decision Making skills. Teamwork and Coaching others. Negotiation and Influence skills. Investigation skills. Auditing documentation and operation process. Demonstrated ability to interact with regulatory agencies. Relevant experience: Bachelor’s degree in a Science related field is required. 8+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2322 days ago