Document Controller

3 weeks ago

Elstree, United Kingdom BPL Full time

Bio Products Laboratory (BPL), part of Kedrion, is recruiting for a Document Controller to support the Quality Assurance department with the creation, issue, copy control, archiving, and recorded distribution of all quality-controlled documents on the BPL site.

This role is ideal for a professionally-minded individual who has strong administrative skills and who is meticulous, can prioritise in a fast-paced and changing environment, and has the ability to assess and initiate things independently. Effective team working and liaising with employees in across multiple departments across site is an important part of the role.

If you have previous experience of writing up, issuing, and amending documents yourself, across any industry where quality is paramount, then this could be an ideal role for you. Alternatively, if you have experience of office or administration skills, this role may match your career goals.

We are looking for someone with experience of using Windows-based software packages such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat.

**Duties & Responsibilities -**

**Document control**
- Document control activities include_:

- Issuance of unique identifications for controlled documents and maintenance of the identification system.
- Issuance and distribution of approved procedures and instructions, ensuring timely return of superseded copies.
- Issuance of batch manufacturing records in response to medium or short-term notice of changes to planned production programmes.
- Preparation and recorded issuance of procedures, forms and other controlled documents including equipment logbooks and laboratory notebooks.

**Maintenance** and **revision of documents**
- Other documentation duties include_:

- Maintenance of an electronic register of controlled documents.
- Creation and revision of controlled documentation using approved procedures.
- Initiation and monitoring of document reviews and recall of superseded documents.
- Maintenance of the electronic and paper document archive system.
- To support departments with Good Documentation Practice and maintaining documentation compliance.
- Carry out auditing as required.
- Helping in the planning stages of any required project.

**Archivist**
- Archiving duties include_:

- To provide training on relevant Quality Systems when required Document Control on TrackWise and Archiving Training
- Monitor the temperature and humidity within the GxP Archive Room daily (other than weekends or Bank Holidays).
- Perform regular checks on the archiving status.

**Other duties**
- Other duties include:_
- Support delivery of site and departmental objectives.
- Participate and contribute to the continuous improvement of the department.
- Ensure effective communication within the organisation and the Quality Group.
- Support manufacturing and other operations in the development, implementation and maintenance of cGxP standards.
- To support revisions to all aspects of the quality system as required.
- To provide administrative support to the Head of QA GxP Compliance and the Documentation Control Manager as required.
- To carry out other duties in relation to QA / documentation control as required.

**In return we offer -**
- Competitive salary
- Bonus
- 25 days holiday
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- My Healthy Advantage phone app
- Virtual GP
- Cycle to work scheme
- Subsidised canteen

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