Document Controller Manager

We are currently looking for a Document Controller Manager to join a growing life sciences company based in the Hertfordshire area.

As the Document Controller Manager you will be responsible for providing leadership and line management to the Document Controllers, coordinating their workloads and drive an environment of continuous improvement and making up part of the Document Control Unit responsible for the creation, issuance, copy control and recorded distribution of all quality controlled documents on site.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Document Controller Manager will be varied however the key duties and responsibilities are as follows:

1. Management Responsibilities - To build and train an effective team to cover the documentation and archival activities and also drive through improvements for the department. You will provide day-to-day supervision and assistance to Document Controllers, and ensure development of Document Controllers using SMART objectives.

2. Documentation Responsibilities - Develop, administer and maintain quality assurance procedures and activities required to ensure that processes and products are in compliance with applicable quality standards and regulatory requirements. Creation and revision of controlled documentation using approved procedures. Issuance of unique identifications for controlled documents and maintenance of the identification system. Issue and distribution of approved procedures and instructions, ensuring timely return of superseded copies

3. Documentation Responsibilities - Preparation and recorded issue of procedures, batch records, forms and other controlled documents including equipment logbooks and laboratory notebooks. Maintenance of an electronic register of all controlled documents. Initiation and monitoring of document reviews and recall of obsolete documents. Generation, review, revision, recall and archival of all GMP documentation, including preparation of technical and manufacturing documentation

4. Archival Responsibilities - To act as the 'Site Archivist' in managing the GMP/GLP Archive and manage the Deputy Site Archivists, acting as the lead person for Archiving in all internal and external audits. You will be the archivist is responsible for the management, operations and procedures for archiving in accordance with established Standard Operating Procedures and the Principles of GLP

5. People Management - Responsible for the management of team leaders, specialists (and analysts in the absence of a team leader). Undertaking recruitment, annual performance reviews, performance management, disciplinaries (up to final written warning), training, and mentoring. Development and delivery of the strategic training plan for the section and across process areas. Developing career progression for staff in the section. Ensure that effective and target driven one-to-ones are delivered across the department.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Document Controller Manager we are looking to identify the following on your profile and past history:

1. Degree qualified, with experience working within a document control setting, ideally within a regulated sector (eg. pharma, biopharma, healthcare, food / beverage, consumer goods, oil & gas, petrochemical etc).

2. Proven industry experience implementing and using an electronic data management system. In addition, experience transitioning from paper based system to an electronic system would be valuable.

3. Project management experience, and an eye for detail. You will also have experience managing and leading a small team.


Key Words: Document control | electronic data management | project management | team leader

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.