Compliance Process Engineer – Oxfordshire

Jason Johal at CK Science is currently recruiting for a Compliance Process Engineer  to join a global, broad-based health care company at their site in Oxfordshire.

The Role:

This aim of this Compliance Process Engineer job is to coordinate and direct compliance issues within the Operations Engineering department of a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. They will ensure a consistent approach is taken to resolving quality issues including ERs, CAPAs, Calibration Alerts and Post Investigations.

Responsibilities:

The responsibilities of this Compliance Process Engineer role will include:

  • Providing technical support to the calibration department to ensure that all calibration activities meet divisional and corporate requirements.
  • Supporting the introduction of new products and / or equipment through effectively managing the engineering document change process.
  • Seeking new ways of improving the efficiency of the Engineering Compliance group. Actively promoting the use of continuous improvement programs.
  • Developing strong links within Operations department to ensure service provided meets business requirements.
  • Understanding regulatory and corporate requirements to ensure the Operations Engineering department continues to meet cGMP and leading teams to deliver compliance projects and quality initiatives.

The successful incumbent will be expected to develop projects from concept through to implementation with the aim of continually improving Engineering processes including preventative and demand maintenance programs. They will also be responsible for authoring, reviewing and updating Operations Engineering documents to ensure compliance with regulatory, site and corporate requirements and for providing SME support to internal and external audits as required.

Qualifications and skills:

The ideal candidate for this Compliance Process Engineer job will have experience within a regulated industry, preferably medical devices or pharmaceutical along with a proven knowledge of engineering and calibration processes. They will also have:

  • The ability to take prompt action to accomplish objectives and to work under their own initiative.
  • A proven track record of technical report authoring and of delivering assigned projects / goals to on time, within budget and ensuring that internal customer requirements are meet.
  • Experience of working within a high volume highly regulated manufacturing environment with full membership of a recognised professional Engineering or Quality body is desirable.

How to apply:

Apply online for this role

For more information or to apply for this Compliance Process Engineer role please contact Jason Johal on 01438 743 047 or email jjohal@ckscience.co.uk. Please quote reference ST23812 in all correspondence.

 

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