QC Document Controller

3 days ago

Louth Co Louth, Ireland WuXi Biologics Ireland Limited Full time

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: As QC Document Controller, youll be responsible for documentation generation and the maintenance of documentation systems within the QC department. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies. Department Description As QC Document Controller, youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting to the QC Operations Senior Scientist. Essential Duties and Responsibilities Responsible for maintaining the company GMP paper-based and electronic documentation programs and be responsible for the control and distribution of QC records and overseeing the implementation of quality documents in QC. Establishment and Maintenance of Electronic and Paper Document Management System through the following: Issuance and recording of document numbers. Receive, confirm and review the final template of document and print the master file for the author, where required. Keep and maintain templates for GMP documentation. Be responsible for arranging documents to take effect and inform involved departments and document coordinators by email. Be responsible for the on-site distribution, retrieval and destruction of controlled documents. Be responsible for updating and maintaining QC document directories (general, project and audit). Be responsible for the regular review of QC documents, preparing the annual review plan, documentation distribution and notifying coordinators of each department. Be responsible for periodically tracking the status of QC document re-review, summarising and reviewing the implementation of regular document review and report: Responsible for the preparation and control of QC forms/notebooks. Responsible for the control and distribution of QC analytical methods and specifications. Responsible for QC protocol/report control and distribution. Responsible for the use and management of QC laboratory notebooks. Assist in the drafting, approval and distribution of other QC quality system documents related to Wuxi Biologics and promote the consistency of quality management. Support during audit preparation and provide any QC documents and records required during the audit. Be responsible for the preparation, revision, review and personnel training of QC SOPs related to document management. Support archival and reconciliation process. Assist in Trouble shooting with management and formatting of documents. Act as QC SME on MasterControl from a QC doc control perspective. Perform all duties in accordance with GMP requirements, SOPs and controlled documents. Flexibility to take on additional tasks and responsibilities at the discretion of the Line Manager. Requirements: Technical Competencies Excellent computer skills MS Office (WORD, EXCEL, PowerPoint) Excellent organizational skills, prioritizing abilities and work efficiently Capable of planning ahead to ensure any problems are resolved promptly and accurately Excellent communication and interpersonal skills. Experience 5+ years experience working in a fast-paced environment. Experience in a GMP facility, in documentation role is desirable Experience with facility start-up projects (brown field or green field) is desirable. Knowledge Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage. Qualifications Diploma / degree qualification is desirable. Behavioural Competencies Collaborative and inclusive approach to work and your colleagues. Excellent problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer. Skills: GMP Documentation Microsoft Excel MasterControl Benefits: Bonus Life Assurance Paid Holidays Parking Pension VHI

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