Senior Specialist - QA Documentation Management (m/f/d)

at  WuXi Biologics

KEY ACCOUNTIBILITIES:

• QA document Administrator Role in EDMS (MasterControl),
• Provide guidance to different departments and perform monitoring of documentation lifecycle in paper and in the EDMS, in compliance with Good Documentation Practices, GxP and internal regulations,
• Provide Documentation Management related metrics for quality purposes,
• Create, Review, and edit documents as per company´s procedures and templates, keep oversight and ensure correct document properties (metadata) and document references, monitoring document status, distributions, paper reconciliation and archiving,
• Represent Wuxi Biologics as SME for Documentation Management for client audits and regulatory inspections.
• Handle Deviations, Change Controls, CAPAs,
• Support Management Review, Annual Product Review, Audits,
• Align the Quality Systems with WuXi Biologics requirements, Continuous evaluation and assessment of documentation-related systems and programs, reviewing results and effectiveness, and designing and proposing improvements.

REQUIREMENTS:

• Knowledge of Good Manufacturing Practice (GMP); ICH, EMA, US FDA regulations; Quality Management Systems (e.g., Pharmaceutical, ISO 9001) is desired,
• Expertise in Microsoft Office Programs, e.g., Word, Excel, Power Point; Outlook, Sharepoint and Teams. Adobe Acrobat, Visio and EDMS experience a plus,
• Experience with EDMS, documentation workflows and following standard operating procedures; Knowledge of document control and good documentation practices, ideally MasterControl, and
• Experience with Documentation Management is preferable.

SKILLS

• Superior written and verbal communication and interpersonal skills,
• Critical thinking, troubleshooting and problem-solving skills,
• Attention to detail and organization,
• Aptitude to learn technical topics quickly and continuously in Quality Assurance and Biotechnology,
• Self-motivation and ability to work in teams and to develop and maintain effective interdepartmental partnerships, and Flexible to handle changing priorities, deadline, and requirements in a fast-paced, demanding environment.

Please refer the Job description for details