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Quality Lead (pharmaceutical)

We are a global healthcare / Biotechnology company specialising in the on-going development and commercialisation of products targeting cancer, critical care and other disorders.

We have recently launched two highly innovative injectable products onto the market that are ground-breaking in their ability to treat cancer and cure other disorders.

We currently have an opportunity for a Quality Lead, QMS Support on a 12 month fixed term contract basis to cover maternity leave.

The Quality Lead will provide technical support and oversight of the global Electronic Document Management System, and GXP Training System.

Provide quality and compliance support and administrative service for the effective functioning of the Quality Management System.

Provide guidance to other sites as required.
To support Quality management activities for Pharmaceutical PEM combination product and Medical Device Embolic Bead range of products in the Quality Assurance Department ensuring all goods manufactured and services provided by the Company meet cGMP and quality requirements of the Company, customers and regulatory authorities.

Principal Responsibilities
, To be responsible for the effective management and system administration of the company Global Electronic Document Management System and GXP Training System.
, Organise the issue, distribution, archiving, reconciliation and destruction of quality system documentation when required.
, Manage and co-ordinate ISO Standards through BSI for business use.

Manage the control and ordering of standards e.g.

, Responsible for the storage of original certifications from BSI and MHRA.
, Ensure compliance in meeting Good Documentation Practice and Good Manufacturing Practice requirements for documentation.

Assist with the development and implementation of global procedures and policies.
, Responsible for the Issuing Batch Manufacturing Records and Issuing unique numbers and maintaining registers for Quality documentation
, Support quality system processes in parallel with other stream leads to ensure effective management of the Farnham Quality System.

This can include Validation compliance, change controls, Quality events, CAPAs, Customer Complaints.

Ensure that departmental objectives are implemented in line with the overall Quality /Corporate goals.
, Assist in ensuring departmental understanding and compliance with the requirements of cGMP as applied to Farnham range of products.

As required, provide cGMP training support to departments.
, Ensure effective coordination and QA leadership for the Farnham Internal audit Process, inspection readiness and audit management.

Focus on Continuous Improvement opportunities.
, Maintenance of Quality System Dashboards, scorecards I Key Performance Indicators for the quality system processes.

Review and monitor trends, communicating out-of-norm issues to department management.

Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review meetings, particularly for the Documentation and training system.

Assist in providing quality system training as appropriate.
, Planning of batch release activities in line with Supply Chain requirements.
, Support in the generation of APQR reports and communication with relevant SMEs.

Education and Experience (preferred)
, Preferably Degree in science discipline (chemistry, biology or medical technology preferred).
, Experience in a drug/medical device manufacturing and Quality Assurance
, Knowledge of document control systems and training systems
, Knowledge of cGMPs, Notified Body, MHRA, FDA regulations and SOPs
, Advanced computer skills - Microsoft Office preferred.
, Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience.
, Demonstrated success working in a team environment.
, Quality professional and diligent in all matters of compliance
, Excellent co-ordination, planning and communication skills

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

  • Start: ASAP
  • Duration: 12 month FTC
  • Rate: £32000 - £38000 per annum + £neg. DOE + Benefits
  • Location: Farnham, England
  • Type: Permanent
  • Industry: Electronics
  • Recruiter: Orion Electrotech Ltd
  • Tel: 0118 9239 239
  • Fax: 0118 9753 332
  • Email: to view click here
  • Posted: 2016-08-16 09:37:18 -

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