The Documentation Control Lead is responsible for the management and quality oversight of GxP Documents within Global and Site-based Operations as per the company’s Quality Management System (QMS). Operating within the Quality Systems team, the position will manage the GxP documentation life cycle from co-ordination, issuance to archival and will drive continual improvement of the Document Management system. The successful candidate will be a leading contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the biopharma industry.
• Ensure that all aspects of the documentation system are proactively managed in compliance with the company’s QMS and relevant cGMP regulatory requirements.
• Partner with global and BDS operations to drive the on-time delivery and control of GxP documentation to support manufacturing operations and packaging activities.
• Support the governance of the company’s QMS performance including Risk Management, Deviations/CAPA’s, Change management, Periodic review as per the relevant standards and policies.
• Responsible for driving Right First Time and Continuous Improvement across the documentation systems network including initiating quality improvement plans and leading resolution of remediation activities from CI or inspections.
• Provide support for internal and external inspections as required.
• Maintain an up to date knowledge of pharmaceutical legislation and industry practice.
• Coordination activities for GxP Document Management in the company’s eDMS.
• Management and coordination of the archival process including onsite and off-site archival and retrieval.
• GxP Logbook Management including issuance and reconciliation.
• Managing the Manufacturing Batch Record process including Issuance and Reconciliation.
• To collaborate with colleagues on the continuous improvement of the eDMS and related e-Systems.
• Builds partnerships across the business to create a culture that demonstrates excellence in documentation quality compliance.
• Provide quality documentation support, oversight and guidance for deviations and investigations and ensure robust root cause analysis/CAPA and timely closure as per company SOP’s and QMS.
• B.A. / B.Sc. or equivalent in Biological / Chemical sciences, or a related pharmaceutical science field or equivalent experience in a regulated industry.
• Minimum of 10 years’ experience in a cGMP environment preferably within a Quality Management role within biopharma.
• The person will have direct experience of GMP documentation management within a pharma/biopharma/medical device company including exposure to regulatory agencies or other authorities of similar standing.
• Planning and organisational skills to plan, execute and track the quality documentation commitments to meet schedules and adjust quickly to changing priorities.
• A strong understanding of the concepts and systems applied to cGMP operations.
• Proven experience with Technical Writing and Problem-Solving methods.
• Ability to direct effective quality management programmes in a highly regulated and high-risk environment.
• Excellent interpersonal skills to enable the ability to communicate well, both verbally and written.
• Strong knowledge of electronic Document Management Systems and computer programs (Microsoft Word, Excel, PowerPoint.)
• The individual in this position is expected to represent company interests, objectives and policies in a responsible and professional manner.
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