Regulatory Compliance Manager

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A global leader in sustainable technologies and one of the oldest pharmaceutical companies is recruiting for a Regulatory Compliance Manager to join their Regulatory team in Edinburgh.

Following the increasing need by Regulatory Authorities focusing on the continual management of Data Integrity, my client has approved a new position to focus on this area. The role will have a multiple site responsibility giving you a fantastic experience liaising with Manufacturing Stakeholders, and all those involved in the Compliance process. This is a crucial role to the business with the sites manufacturing complex pharmaceutical products, which drastically effect the lives of those suffering from Parkinson's and ADHD.

In this role, you will manage and support regulatory activities in Edinburgh, ensuring adherence to required guidelines. You will support the Director of Quality & Regulatory Compliance on compliance activities including change control, customer audits and quality metrics monitoring. You will be liaising with staff at all levels providing regulatory compliance as required and increasing overall awareness. You will also deputise for the Director of Quality & Regulatory Compliance in compliance activities.

Other responsibilities for this role include:

* Reviewing and approving change controls and batch documentation

* Reviewing and approving failure investigations and CAPAs

* Performing Risk Assessments and supporting other departments during Risk Analysis

* Assisting with complaint investigations and writing up of reports

* Assisting in the preparation of GMP training programs within the Edinburgh facility

* Managing to quality metrics monitoring of Trackwise data providing oversight and reports as required

* Holding customer quality audits in Edinburgh and providing written feedback

* Supporting QA in auditing the business' service and material suppliers

The Ideal Candidate will have:

* Educated life science or related subject

* Experience in the Pharmaceutical Industry is essential

* Knowledge and experience of FDA & MHRA requirements is essential

* Computing skills - particularly in the use of databases and spreadsheets would be an advantage

Personal Qualities required for this role:

* Reliable and conscientious worker with proven communication skills

* Able to make key decisions using information and resources available

* Being able to work under own direction

* Able to operate in close conjunction with QA, Production, Engineering, Development and other affected departments

This position is a great opportunity for anyone looking to make a bigger contribution to the overall business not wanting to be a small cog in a large machine. The role offers excellent benefits and remuneration, if you are interested, please let me know by way of email or phone call, or if you have any contacts in your network who you think may have an interest in this position, please feel free to pass their details on to me.

Sthree UK is acting as an Employment Agency in relation to this vacancy.