Qms Archivist/ Administrator

**Introduction to role**:
An exciting opportunity has arisen to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities. Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals. We develop new vaccines, therapeutic proteins, and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

PBL offer a competitive benefits package, including:

- 30 days of holiday, plus 8 bank holidays.
- On the job training, and genuine opportunities for growth and advancement.
- Generous pension scheme.
- Access to online discounts.
- A work environment based in the beautiful Salisbury countryside, with free on-site parking, easy access to London and the south coast.
- Life Assurance

**Key Responsibilities**:
The postholder will support the administrative tasks linked to the Quality Assurance Department and its Quality Management system (e.g. Documentation control, training, change control, risk management, non-conformance).

This includes the management of, distribution, control and tracking of all GxP Documents (including identification, filing, scanning and the archival of records) using PBL systems.

There is also requirement that the postholder will be expected to respond to any specific management, outsourced and third-party requests which may include the compilation of data, reports and documents as well as preparation and supply of documents at audits and inspections
- To manage and co-ordinate the administration of all types of quality documents in the eQMS which will include the full document lifecycle from formatting, inputting, routing, reviewing and the approval processes in the eQMS.
- To perform administrative tasks associated with the management of the Quality systems, databases, paperwork or e-system for the following systems: training, change control, non-conformance, risk management.
- To assist personnel with administrative tasks (i.e. document lifecycle activities) on the eQMS
- To operate and maintain the archive tracking system.
- To liaise with the external archive provider(s) and ensure that all documents are processed effectively and efficiently as per the archive retention policy and procedure.
- To prepare records for archive storage and retrieval of retained documents during their retention period.
- To produce reports, metrics, documents, SOP’s and respond to any specific requests in relation to using the eQMS, and other documentation management systems at PBL. This is particularly critical for key governance meetings e.g., QMRB or QREV, and for any external and internal audits and inspections.
- To provide general office administrative support to the team, e.g., Filing, photocopying, ordering consumables/stationery.
- Undertake work in accordance with Porton Biopharma’s Health and Safety policies and procedures and Quality systems.

The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the Manager.

The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organization

**Personal Specification**:
**Experience**

**Essential**: previous admin experience using computer data systems, document control or archive experience. Working knowledge of Microsoft office & databases.

**Desirable**: understanding of data protection legislation, experience in a health care / pharma environment

We are looking for a team player with good communication and interpersonal skills, who has a methodical approach and attention to detail to tasks, also with the physical ability to move boxes of files.
- NB: This is a site based role and as PBL is in a rural location with limited public transport available, the ability to drive with own transport would be of benefit._