QA Senior Documentation Specialist

at  WuXi Biologics

QA SENIOR DOCUMENTATION SPECIALIST

The QA Senior Documentation Specialist will be responsible for documentation generation and the maintenance of documentation systems. Introduction of process improvements associated with the handling of documentation across the site ensuring data integrity requirements are met. Support site level ownership of the Training and Document management system and the archiving of site documentation.

ORGANIZATION DESCRIPTION

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re 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, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

DEPARTMENT DESCRIPTION

As QA Senior Documentation 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 to the QMS Lead.

QUALIFICATIONS

• Degree in Biopharmaceutical Science or other related science discipline

KNOWLEDGE/EXPERIENCE:

• Minimum of 5 years’ experience working in a fast-paced environment with relevant experience in a GMP facility, within Quality, responsible for a documentation management system.
• Experience in the operation of electronic and paper-based systems for the management of data in a GMP environment including data integrity requirements.
• Familiar with ICH, EU, FDA and GMP regulations.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
• Excellent computer skills MS Office (WORD, EXCEL, PowerPoint)

Essential duties and responsibilities of this role include and are not limited to the following;

• Coaching/mentoring, and training for a headcount of approximately 3 people.
• Maintaining the company GMP paper-based and electronic documentation.
• 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.
• Maintain templates for GMP documentation.
• Arrange documents to take effect and inform involved departments and document coordinators.
• On-site distribution, retrieval, reconciliation, and destruction of controlled documents.
• Updating and maintaining document directories (general, project and audit).
• Periodic review of SOPs, preparing the annual review plan, documentation distribution and notifying coordinators of each department.
• Control and distribution of QC analytical methods and specifications.
• Be responsible for the use and management of laboratory notebooks.
• Provide site training on the training management system Master Control.
• Assist in the drafting, approval and distribution of other quality system documents related to Wuxi Biologics and promote the consistency of quality management.
• Act as SME for Quality system, updating and reviewing SOPs according to the latest GMP regulation and industry practice.
• Generate and review change controls and deviations as applicable.
• Introduce continuous improvements ensuring data integrity requirements are continuously met.
• Flexibility to take on additional tasks and responsibilities at the discretion of the QMS Lead.
• Act as a role model for the Quality Organisation – Speak with one quality voice and demonstrate PROUD values and behaviours.