Quality Operations Manager

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. United Kingdom
Surrey
Posting date: 10 Jan 2019
QA.CM.21004_1547135963

Our client, a global pharmaceutical company is seeking a Quality Operations Manager to join their team in Surrey, UK on a contract basis.

Job Role:

The Quality Operations Manager provides a Quality Assurance service to the consumer health business unit by way of Subject Matter Expertise in the GDP Quality Management system. This role ensures a high-quality performance of the consumer health business's supply and distribution activities in accordance with internal quality standards and ensures compliance with GDP standards, inspection readiness, training, process improvements and Board of Health contact for product quality related issues.

Job Responsibilities include:

Quality System Management

  • Lead the deployment and training of applicable GDP and Product Quality Management Systems
  • Collect Key Performance Indicators (KPI) for GDP metrics reporting and present/report to Quality management and key stakeholders.
  • Monitor local quality and compliance environment to ensure regulatory expectations concerning product quality are met by adjusting/enhancing local systems and processes when required and informing leadership and above country stakeholders of changes/new requirements.
  • Contribute to regional and global quality strategic initiatives
  • Quality consulting activities (e.g answer to queries on distribution and supply activities impacting product quality, liaison between market and manufacturing site quality representatives)
  • Responsible for UK Board of Health contact in relation to product quality defect notifications and customer complaints

Local Product Disposition

  • Conduct local release of receipted products, in compliance with local procedures, prior to distribution/sale within the UK.
  • Lead the communication with the Business Units to prioritise batch release based on urgency of market needs, achieving Service Level Agreement.
  • Compile KPI figures for reporting purpose to the UK business and Quality organisation.
  • Lead the communication of KPI figures to the UK business and Logistic Service Providers.
  • Conduct assessment of returned product in cooperation with the local logistics service providers (LSP) and advise appropriate disposition decision to management Quality oversight of third-party contractors
  • Support the RP with the quality oversight of UK managed third party local packaging/labelling vendors and distribution centres.
  • Develop and maintain an effective distribution and repackaging vendors oversight and inspection plan.
  • Ensure Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards implementation by those 3rd party vendors.
  • Monitor quarantine product movement and provide status control.

Education, Skills and Experience:

  • Life Sciences degree is required: BS or MSc and over 3 years experience in GDP/GMP or related field.
  • Knowledge of the regulatory GDP/GMP compliance issues relating to manufacturing and distribution of medicinal products
  • Experience with Board of Health communication and hosting external inspections
  • Previous experience in a GMP/GDP role in a regulated environment is required
  • Previous experience in a role involved in the drug development process is valued
  • Supervisory experience in a matrixed organization is valued Desired technical and behavioural skills:
  • Fluency in English

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caeb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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