Document Controller

2 weeks ago

Elstree, United Kingdom Bio Products Laboratory Full time

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

This role is ideal for someone who has strong administrative skills, who is meticulous, can prioritise in a pressured and changing environment, and has the ability to assess and initiate things independently.

If you have worked in a team where you are writing up, issuing, and amending documents yourself, such as within a supply chain role or procurement, then this could be an ideal role for you.

We are looking for someone with excellent IT skills, including window-based software packages such as Microsoft Word and Excel, Power Point and Adobe Acrobat DC.

**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- Issuance and distribution of approved procedures and instructions, ensuring timely return of superseded copies.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- Initiation and monitoring of document reviews and recall of superseded documents.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
- Locations- Elstree**About BPL**:
BPL in its present form was created in 2010, but its heritage stretches back to the early pioneers of blood and plasma-derived medicines in the UK.
- Founded in 2010- Co-workers 5000

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