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 and Asia. The company currently employs over 12,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: The Doc Control & Training QA Specialist will be responsible for documentation generation and the maintenance of documentation systems within the QA department. Department Description As Doc. Control & Training QA Specialist, you will be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Doc. Control & Training QA Team Lead. Your Responsibilities: Responsible for maintaining the company GMP paper-based and electronic documentation. Responsible for the control and distribution of records and overseeing the implementation of quality documents in each department. 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. 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 document directories (general, project and audit). Be responsible for the regular review of documents, preparing the annual review plan, documentation distribution and notifying coordinators of each department. Be responsible for periodically tracking the status of document re-review, summarising and reviewing the implementation of regular document review and report: Responsible for the preparation and control of forms/notebooks Responsible for the control and distribution of BPRs Responsible for the control and distribution of QC analytical methods and specifications Responsible for protocol/report control and distribution Be responsible for the use and management of laboratory notebooks Standardise the writing of document records and the requirements for second person review. Assist in the drafting, approval and distribution of other quality system documents related to Wuxi Biologics and promote the consistency of quality management. Prepare the audit materials and documentation list according to the daily audit arrangement, and provide any documents and records required after the audit. Be responsible for the preparation, revision, review, and personnel training of SOPs related to document management. 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 QA Document Control Manager. Will act as a role model for the QA function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile: The ideal candidate for this position will have the following: Education Diploma/Degree qualification is desirable. Knowledge/Experience Required: Minimum of 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 / experience in the operation of GMP Pharmaceutical Sites would be an advantage. Personal skills Preferred: Collaborative and inclusive approach to work and your colleagues. 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. Excellent problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. 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 mission - 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! WuXi Biologics is an equal opportunities employer. Would you like to know more before you apply? Please visit us at or contact us via Skills: Attention to Detail Compliance Data Integrity Benefits: Canteen Parking Pension Sports & Social Club VHI