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Quality Systems Officer (contract) Oxfordshire

Quality Systems Officer (contract) Oxfordshire

Job Title: Quality Systems Officer (contract) Oxfordshire
Contract Type: Contract
Location: Oxfordshire, England
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QualSystems_1503648284
Contact Name: Nathan Wilson
Contact Email: n.wilson@sciproglobal.com
Job Published: August 25, 2017 09:04

Job Description

Job Purpose

  • Designing and providing continuous improvement of Quality Management Systems.
  • Monitoring and production of metrics of GMP compliance with current Quality Management Systems.
  • Supporting all aspects of supplier qualification and ongoing risk management.
  • Providing primary Quality support for new products, projects and suppliers/service providers as required.
  • Conducting internal audits and following up to promote continuous improvement.
  • Supporting Annual Product Quality Reviews as required.
  • Supporting the hosting of client and regulatory audits and inspections.
  • Supporting and co-ordination of responses to client and regulatory audits and inspections.
  • Acting as a point of contact for client quality assurance queries.

Responsibilities

  • Supporting the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/ testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations.
  • Providing direct quality team support during customer and regulatory audits.
  • Creation and maintenance of a state of readiness in order to satisfy regulatory and client expectations during audits and inspections.
  • Working in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
  • In depth knowledge of the pharmaceutical industry in terms of regulations and compliance.
  • Awareness and understanding of Quality Systems in order to support them effectively.
  • Communication of compliance updates.
  • Knowledge of the different aspects of the OXB business in order to assist in investigations.
  • Actively support continuous improvement of Quality Management Systems, representing Quality in new projects to ensure quality is built in as early as possible.
  • Supporting Quality based projects working as part of a multidisciplinary team as required.
  • Promoting continuous improvement of the Quality Management System ensuring that the manufacturing and or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
  • Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
  • Reporting on-going progress with QA activities and Deviations to Head of Quality.
  • Attending meetings and follow up communications across the Quality Systems team and other departments.

Key skills and requirements

  • Familiarity working within pharmaceutical Quality Assurance.
  • Working knowledge of GMP & Quality related pharmaceutical regulations & standards.
  • A level, National Certificate or equivalent in a Science discipline.
  • Higher National Certificate, Degree or equivalent in science discipline is desirable.
  • Computer literate (Word, Excel, MS Office).
  • Solid working knowledge of Validation and Quality Management systems.

Requirements

  • Experience of conducting quality based audits, investigations and root cause analysis.
  • Understanding and experience of Change Control.
  • Experience of regulatory and or customer /client audits and inspections.
  • Understanding & experience of GMP and pharmaceutical industry QA requirements.
  • Experience in document control or records management systems in a regulated environment.
  • Good interpersonal and communication skills.
  • Excellent attention to detail.
  • Good team player, and must also be able to work alone.
  • Good organisational and time management skills.
  • Able to prioritise workload, decisive thinker and able to work within agreed timescales.
  • Experience of use of an electronic Document Management system to GMP standards.