QA Document and Training Specialist

The QA document and training specialist sits within the German Quality organization and will be responsible for documentation generation and maintenance, and training management in Wuppertal (MFG19) and Aprath lab.

Department Description

As QA Document and Training 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 QA Ops Team Lead.

• Responsible for GMP training business management, including but not limited to: training management of GMP personnel, maintenance of GMP training system and job codes of all departments to ensure efficient and compliant operation; training business operation, maintaining GMP training files; Organize and support the implementation of GMP training program.
• Act as training managers and QA training coordinator.
• Track training performance and remind/ escalate in case of overdue trainings.
• Responsible for maintaining the company GMP paper-based documentation programs and also be responsible for the control and distribution of records and overseeing the implementation of quality documents in each department.
• Establishment and maintenance of Electronic and Paper Document Management System through: 1. Issuance and recording of document numbers; 2. Receive, confirm and review the final template of document and print the master file for the author; 3. Keep and maintain templates for GMP documentation.
• Be responsible for arranging documents to take effect, and inform involved departments and document coordinators.
• 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 review, summarizing and reviewing the implementation of regular document review and report: such as forms/notebooks, BPRs, QC analytical methods and specifications, protocol/report, and laboratory notebooks.
• Standardize 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 consistence of quality management.
• Be responsible for the preparation, revision, review and personnel training of SOPs related to document management.
• Perform additional duties at the request of direct supervisor.

Qualifications/Experience

• A Bachelor’s degree in a technical discipline would be an advantage.
• At least 2 years of relevant working experience in the pharmaceutical industry
• Strong oral and writing English (Chinese and German is a plus).
• Solid understanding of GMP and European regulations (German drug law is a plus).
• Results oriented and ability to deliver under pressure in a fast paced environment.
• Think individually with a strong sense of service, decisiveness and responsibility. Good knowledge of Microsoft Office – Powerpoint, Word, Excel.
• Good organizational skills.
• Good interpersonal communication skills.
• Excellent oral & written communication skills (English; German is preferable).

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 Biologics is an equal opportunities employer.