QC Document Controller
As QC Document Controller, you will be responsible for documentation generation and the maintenance of documentation systems within the QC department.
Department Description
As QC Document Controller, you’ll 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’ll be reporting to the QC Operations Lead.
Your 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.
- 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.
- Be responsible for the use and management of QC laboratory notebooks.
- Standardise the writing of document records and the requirements for second person review.
- Assist in the drafting, approval and distribution of other QC 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 QC documents and records required after 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 EDMS 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.
- Will act as a role model for the QC 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:
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/Knowldege:
- 3+ 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.
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.
Closing Date for Applications: Wed 15th April at 5pm
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! Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via [email protected]
WuXi Biologics is an equal opportunities employer.
