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QMS Specialist - 12 months

South Yorkshire, United Kingdom

  • Salary: Dependent on experience
  • Job type: Interim/Contract
  • Posted: 29/11/2017
  • Contact name: Frankie Cunningham
  • Contact number: 01892 612612
  • Ref: 2789

Job description

Job Description:

We are looking for a scientific graduate at our client's site in south Yorkshire. The successful candidate will come from a scientific background, ideally with experience of pharmaceutical manufacture or Quality Control in a GMP environment. 
General Responsibilities:

To help ensure our client's compliance with the requirements of Good manufacturing Practice and Regulatory Rules and Guidelines and contribute to the company quality assurance functions. 

Specific Responsibilities:

  • Preferably, experience in Quality Assurance for production of Sterile injectable products but is not essential.
  • Ideally has a practical experience in activities of quantitative and qualitative analyses of active substances and of the necessary testing and checking to ensure the quality of medicinal products or associated relevant experience.
  • To ensure that batch records and other documentation is completed to the expected standards during the Batch Review and Release process.
  • To ensure, via the site Qualified Person, that the Quality Management System is managed and maintained to the requirements and standards set down in Company Policies.
  • To collate process deviations and laboratory investigations ensuring that problems are addressed in compliance with GMP and our client's procedures. 
  • To prepare information for the periodic Quality Management Meetings and track the performance against KPIs and the specified standards.
  • To monitor the nature, extent and frequency of complaints
  • To co-ordinate recall/withdrawal procedure.
  • To support site validation activities ensuring that regulatory requirements are met.
  • To co-ordinate and carry out internal site auditing programmes.
  • To act as an advisor to the site team in aspects of Quality and Continual Improvements.
  • To take part when required in site Inspections by Regulatory Authorities. 
  • To help ensure that the RPU is Inspection ready at all times.
  • To support Continual Improvement where necessary as part of ongoing systems management.
  • To take part in the regular Quality Management Meeting
  • To participate in our client's Safety Committee meetings.