Training Compliance Documentation Specialist

Red Eagle Recruitment (AGY) is looking to recruit a Training Compliance Documentation Specialist for our client, a global pharmaceutical manufacturer based in Sandwhich.

The purpose of this job within DPS and CRD Compliance is to maintain and control documentation and provide administrative support for compliance, with a specific focus on Training.

Job Responsibilities

• To provide documentation support for manufacturing areas in CRD and DPS eg procedures validation, batch record templates, active library management.
• To provide documentation support for training including P2L (Power2Learn) admin, associated documentation requirements and support in rolling out training packages.
• To create, assign, modify job roles for GMP technical operations in collaboration with DPS and CRD supervisors/management.
• To create, assign, modify training activities in collaboration with DPS and CRD procedure authors (R&T, WBT, OJTs, ILT).
• To act as DPS and CRD Training Point of Contract (TPOC) for GMP procedure changes to assess the risk of the activity (patient, EHS, compliance) and determine appropriate training activities for novice and currently trained.
• To provide support for investigation leads and SMEs on ensuring the timely progression of quality or safety investigation records by logistics management and documentation support.
• To scribe and electronically control documentation updates in accordance with procedural requirements
• To be responsible for version control and upload completed documents to designated storage such a GDMS
• To collect and measure productivity through agreed metrics.
• Participate in decision making and continuous improvement activities in the SW Training Community and PharmSci Learning Community
• Participates and supports internal, corporate and external audits.
• Ensure that that the clients gets the best possible service by continually reviewing best practice in relation to both commercial, safety and quality issues and ensuring 100% ethical work.
• To learn to deal with clients queries and contact designated personnel with any relevant information or issues relating to documentation, training and systems or the service in general.
• To become fully familiar with and keep up to date with any procedural or technological revisions in their area, ensuring their training is complete and adjusting their work as required with approval from the Compliance Lead in DPS or CRD.

Experience/ Skills

Experience in good documentation practices and filing with Pharmaceutical or other regulated industry.

A sound, fundamental knowledge of Technical Documentation Administration and document management systems is essential

Appropriate relevant experience of technical Documentation Administration in a GMP/GxP environment within a group organization.Basic understanding of DGMP/Validation is desirable.

Ability to quickly learn new processes and electronic systems.

Ability to work using fully electronic media, including MS Office Word, Excel, SharePoint essential, Visio and PowerPoint desirable. Experience of Learning/Quality Management systems would also be beneficial.

Ability to communicate clearly and to form strong working relationships with colleagues

Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them in to relevant improvements. Ability to switch priorities at short notice is desired.

This is a 2 year fixed term contract, working 37 hours a week Monday to Friday. This is paying an hourly rate of GBP13 per hour

To find out more and to be considered for the role of HR Administrator, please apply via your CV.