QC Associate - Npi

Pe Global

Dublin

PE Global are currently recruiting for a QC Associate - NPI for a client site in South Dublin - Primary Responsibilities, Accountabilities and Decisions Rights : • QC Representative for NPI activities and routine Product meetings. • Assist with activities related to QC projects and/or QC tasks within Site projects. • Plan and Perform non-core testing related to NPI activities. • Manage all sample management activities related to NPI activities throughout the site. • Create/own and approve protocols, sample plans, SOP and documentation related to NPI. • Responsible for their own training and safety compliance. • Sample shipments and temperature monitoring activities for NPI activities. • LIMS data coordination of non-core (NPI) activities. Job Summary: Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data 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 Relevant experience: • Bachelor’s degree in a Science related field is required. • 5+ 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. Knowledge: • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning. • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery. • Project Management and organizational skills, including ability to follow assignments through to completion. Competencies: • Demonstrated ability to work independently and deliver right first time results. a. Works under minimal direction. b. Work is guided by objectives of the department or assignment. i. Follows procedures. ii. Refers to technical standards, principles, theories and precedents as needed. iii. May set project timeframes and priorities based on project objectives and ongoing assignments. iv. Recognizes and escalates problems. • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues. • Auditing documentation and operation process. • Demonstrated ability to interact with regulatory agencies. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2046 days ago