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Compliance Manager – Engineering GMP

Compliance Manager – Engineering GMP

Job Title: Compliance Manager – Engineering GMP
Contract Type: Permanent
Location: Kent
Salary: Excellent Salary plus Benefits
Start Date: 2017-04-07
Reference: 15352 JH
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: April 07, 2017 17:16

Job Description

  • Job Title: Compliance Manager  - Engineering
  • Excellent salary plus benefits including Private Medical Insurance, Health Cash Plan, Private Pension, Income Protection, EAP plus others
  • Location: Kent
  • Knowledge of Computerised Systems (e.g. IMS Maximo) ESSENTIAL
  • Supervisory or Management Experience ESSENTIAL

Summary
James Hume is recruiting for a Compliance Manager to take responsibility for the computerised systems, scheduling, and compliance of all engineering activities on their R&D Site in Kent. This site is where their main drug discovery takes place as well as manufacturing, packaging and distribution for clinical trials.  Due to the continued increase in the volume of products entering trails they have invested in this site so that it can meet the increased manufacturing and distribution demands. This role is as a result of this expansion to take ownership of their computerised systems that are being upgraded as well as overseeing the compliance of the Engineering team.

The Company
They have sites located throughout the UK that cover all the different aspects of the development and commercialisation of drugs from discovery to commercialisation.  They are now undergoing a sustained period expansion as they now have successfully launched 2 products with further novel drugs at all phases of clinical trials.  In addition to this they have further products under development which will be moving to clinical trials soon.  Their research is based on a unique cannabinoid technology which is now beginning to meet its potential as they explore its benefits further.  The company are rightly proud of their product pipeline and their aim is to keep their position at the front of research in their unique field.      

The Role
This is will be a key role within the engineering department to work with the Head of Engineering to manage the computerised systems as well as the compliance of the team.  They are making the transition from a manual system to an electronic system (IMS MAXIMO) which you will oversee and once completed take ownership of this.  You will lead continuous improvement initiatives for the site as well as provide technical assistant to the manufacturing sites and have the responsibility for the GxP and H&S for the site applicable to the role.

An overview of the key responsibilities are:

  • Responsible for the engineering electronic systems including IMS and CMMS.
  • Review Data Trends of PPM to ensure a cost efficient and effective services is provided.
  • Oversee the Installation Qualification - IQ, Operational Qualification - OQ, of new plant equipment and assist with Performance Qualification - PQ.
  • Maintain master drawings onsite, including P&ID’s and create and issue CAD drawings when needed.
  • Ensure all documentation is completed to the highest standards and all timelines kept to.
  • Ensure all regulatory and statutory requirements are met all equipment systems.

The company have recently upgraded this site to meet their changing business needs and the increasing scale of activity.  You will support this process using your knowledge to help develop strategies and approach for the engineering department to ensure the site operate efficiently and effectively.

Experience
You will need to be a qualified engineer with a relevant degree with experience in a highly regulated industry such as pharma, biotech, chemical, oil, gas, nuclear etc.  You will need to be familiar with electronic systems used to manage engineering operations such as IMS, Maximo and CMMS.  Ideally you will have GMP experience but experience of working in an ISO: 9000 environment is just as valid.  If you have experience of Auto CAD then this is advantageous to your application.  You skill set can be either mechanical or chemical.

Keywords
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