Job description Posted 04 July 2022

GMP Documentation Author

9 Month Contract

On site working in Ware (Monday-Friday)

Pay rate £19.50 per hour

Job Purpose:

The purpose of the Documentation Author is to create or update key GMP documentation (including, but not limited to, SOP-Standard Operating Procedures, SWI - Standard Work Instructions, Forms). This includes the consistent delivery of the schedule for site documentation creation & update, whist ensuring that all documentation meet a defined set of standards.

Key Responsibilities:

• Operate to a defined work schedule to progress documentation changes in collaboration with other site staff (e.g. document Content Approvers, Quality Approver, Compliance co-ordinator, work placed trainer etc)

• Ensure documents comply with standards and follow good document practices (e.g. clear concise instructions, flowing systematic change processes).

• Facilitate meetings with key staff to gather information and agree content of documents

• Control the issuing and distribution of documents, specifically using the nominated electronic systems such as VQD.

• Assess training needs in collaboration with other site staff to determine the training requirements and create the appropriate training material.

• Perform real time issue identification and resolution, including collaborating with other staff to actively “problems solve” and understand root causes of non-adherence to schedule.

• Create, maintain, adhere to and improve standards (5S and standard work) to improve quality, safety and efficiency.

• Continuous Improvement - Develop solutions to increase overall efficiency/ performance.

Candidate requirements:

The main requirement is to have a good knowledge of GMP and have good written and verbal communication skills.

An advantage is to have experience in authoring documents previously