NPD QA OFFICER (PHARMACEUTICAL MANUFACTURING)

Commutable from Liverpool, Warrington, Chester, Manchester

Up to £35,000 working days (9am - 5pm)

Creative Resourcing, a specialist recruiter working within the manufacturing sector are currently seeking a QA to work for one of our prestigious pharmaceutical clients

THE ROLE

Purpose of the Job:

The main purpose of this role is to give support in the development, implementation and maintenance of quality standards and systems, to ensure that all new product introductions to the site are carried out in compliance with the principles of cGMP.

Key Results areas are:

  • To relay technical knowledge and expertise to peer group in order to ensure all projects are carried out within the principles of Current Good Manufacturing Practise (cGMP), Audit, On Time In Full (OTIF), Right First Time ( RFT);
  • To propose, design and implement more efficient and effective methods of working. OTIF, RFT;
  • To carry out critical reviews of documentation pertaining to New Product Development projects - validation, experimental, stability, reports, Batch Manufacturing Record’s (BMR’S), Audit, OTIF, RFT;
  • To be involved in failure investigation - Non Conformance Reporting (NCR) /Out of Specification ( OOS) and close out with appropriate corrective and preventive measures in place and within timelines; Non- conformance Investigations/Reports, OTIF, RFT;
  • To carry out audits in order to identify action and close out non- compliance issues - internal/ external audit schedule. Audit Schedule, Audit Actions;
  • To support manufacturing operations in the development, maintenance and implementation of GMP standards specifically for new products / developmental processes. Training Modules, Training Records, Training Plans.

EDUCATION REQUIREMENTS

Applicants should have the following experience/qualifications:

  • Degree qualification in a scientific discipline preferably Chemistry;
  • Must have previous experience of working within the pharmaceutical industry in a similar role;
  • Must have Sterile Manufacturing experience;
  • Good understanding of EU & US regulatory guidelines and the product licensing processes;
  • Good understanding of GMP requirements in relation to sterile product manufacture and packaging;
  • Understanding of the principles of sterilisation and aseptic processing;
  • Root cause analysis & Risk Management;
  • Understanding of Lean manufacturing techniques;
  • Understanding of Quality Management Systems.

REMUNERATION

Our client is offering a salary of up to £35,000 coupled with an excellent remuneration package.

This is a permanent opportunity to join a successful and progressive company that continues to enjoy market leader status.

To apply for this position please contact:

Daniel Bunn

This vacancy is being advertised on behalf of Creative Resourcing who are operating as an employment agency.

Please only apply for this position if you possess all the necessary experience and qualifications.

NEW PRODUCT DEVELOPMENT QA OFFICER (PHARMACEUTICAL)
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Tuesday the 19th.

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