QC Specialist - Method Transfer

Pe Global

Dublin

PE Global is currently recruiting for QC Associate (Method Transfer) for a Client site in Dublin: Role Name: QC Specialist (Level 5. Role purpose: QC Specialist (Method Transfer. Overview: This job specification outlines the general responsibilities associated with the role of QC Specialist Method Transfer at clients site. This role will be responsible for owning, coordinating, facilitating, and undertaking activities pertaining to analytical method transfer and/or method validation for new product introduction into the Quality Control laboratories. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the role. Under minimal direction, functions as the technical specialist for Method Transfer and is responsible for the following activities in QC. • 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. Primary Responsibilities and Accountabilities: • Ownership, accountability and provision of Analytical Transfers, NPI and Subject Matter Expertise for key process and associated documentation. • Leading the QC project team and demonstrating the ability to positively influence others. • Creation of Analytical transfer plans, protocols and reports. • Creation of Analytical validation plans, protocols and reports. • Co-ordination of materials and critical reagents. • Authoring and creation of analytical methods, SOP’s and risk assessments. • Support data verification and data appendices. • Provide regulatory filing support for activities associated with method transfer/method validation. • Project Manage the overall Analytical Product Transfer Plan for QC. • Author and manage change control records and provide technical input and assessment for QC. • Successful execution of analytical experiments, organisation of data and interpretation of analytical results. • Interface with all areas affected by the method transfer/NPI introduction, including project stakeholders, governance boards, subject matter experts, end users and other teams working across the corporate network. The QC Specialist is an active role within the broader QC function and will report to QC Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. Authoring, creation and management of change controls and investigations with regard to technical input and direction through the appropriate processes within clients site. This is primarily a desk based role to support the overall Analytical Method Transfer Plan and strategy for QC, with minimal supervision. The role will require strong Project management skills. The role will require a detailed understanding of the requirements necessary to deliver successful analytical method transfers to optimize efficiency and quality within the quality systems and compliance structures. In addition to routine QC duties, QC Specialists may be assigned specific oversight & responsibilities for key quality control systems or processes. QC Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives. The ideal candidate must have a proven track record of Technical Leadership in the industry in Quality or Manufacturing Technology and have a proven track record in successful Project management and delivery of analytical methods. The role requires high motivation, excellent organization skills and the ability to prioritise and execute tasks in a fast moving environment. Primary knowledge, skills, competencies and relevant experience. Key Competencies. • Excellent Technical leadership in Quality and /or Manufacturing Technology. • Excellent Project management and Change management skills. • Experienced in developing and executing project plans, utilising a project management methodology and. project planning and reporting tools. • Results oriented and analytical. • Ability to anticipate problems and take decisive action. • Excellent Organisation abilities. • Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources. • Take initiative to identify and drive improvements. • Communication skills (verbal and written) at all levels. a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls. b. Presentation skills. c. Escalate issues professionally and in a timely basis and know when to escalate. • Decision Making skills – will be require to make decisions independently and incisively. • Teamwork and Coaching others. • Negotiation and Influence skills, Planning and organisation skills. • Investigation skills. • Demonstrated ability to interact with regulatory agencies. Relevant experience: • Bachelor’s degree in a Science related field is required. (Engineering, Science or technology ) • 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with 2 – 3 years of specific method transfer experience is desirable. Experince as Technical leader /Project manager with proven track record. • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. • Highly skilled in MS Office, MS Project, PowerPoint. Visio experience preferable. • Experience in Organisational Change/ Change Management preferred. 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.

2109 days ago