Doc Control & Training QA Specialist

Doc Control and Training QA Specialist

The Doc Control & Training QA Specialist will be responsible for documentation generation and the maintenance of documentation systems within the QA 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 worlds 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 10000 people and provide services to more than 200 customers worldwide including 13 of the top 20 biopharmaceutical companies.

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 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.

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