Document Controller (GCP)

Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is seeking a Document Controller (GCP) to join them on a permanent basis, located in Abington.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Supports the Quality Management System.
• Works closely with the Line Manager and the wider QA team in maintaining the quality objectives and embedding quality culture into the organisation.
• Implements and manages the electronic quality management documentation management system including uploading and archiving documents and handling associated requests.
• Responds to documentation enquiries, giving appropriate access to information.
• Supports in documenting internal and external audits in the QMS.
• Supports other functions in drafting, reviewing and approving documents / records using the QMS.
• Supports the implementation and management of non-conformance and CAPA systems within the QMS.
• Delivers the 'Service Owner' role for the electronic Quality Management System to ensure the system is used by the wider organisation and any error reporting is handled in an effective manner. Also ensures ongoing development and enhancement of the toolset to meet evolving business requirements.
• Provide support within the existing paper based QMS in terms of update, maintenance, drafting, QC of procedural documents.
• Checks / maintains the compliance and quality of the documents, in relation to Standard(s), Guidance and procedures and expectations.
• Supports the ongoing maintenance and improvement of standard operating procedures and user guides in the QA department.
• Reports on progress of documents ensuring that documents are reviewed and approved within the review cycle.
• Provides support to the Line Manager and wider QA team in conducting QA related training to the company.
• Supports in any other tasks as deemed appropriate by the Line Manager.

Key Skills:

• Excellent communication skills, liaising with colleagues and system providers.
• Proven ability to change, prioritise accordingly and maintain strong organisational skills.
• A willingness to be flexible, performing responsibilities not identified in this role specification, and assuming responsibilities as our needs change.
• Must have the ability to work independently and also a good team player, with proven ability to provide practical and pragmatic solutions with speed and efficiency.

Requirements:

• Pharmaceutical or Biotechnology experience essential.
• Experience, most likely gained through delivery of a similar role, with knowledge of administering a Document Control Management System in a Quality / Compliance orientated environment.
• A degree in life sciences or equivalent experience.
• Previous experience with an eQMS is essential (experience of working with MasterControl and/or Trackwise is preferable) writing standard operating procedures and migrating.
• Mandatory experience in a biotech/pharma industry with electronic Quality Management Systems; preferred to have experience in both paper-based as well as electronic systems.
• Excellent Document Administration / IT (MS Office) skill-sets.
• Demonstrated commitment to quality.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.