Quality Specialist - Newhouse

Job Ref: J29375
Sector: Science
Sub-sector: Biotech/Life Sciences
Job Type: Permanent
Date Added: 21 November 2018
  • Airdrie, North Lanarkshire, Scotland, UK Airdrie Lanarkshire UK
  • Competitive
  • Pamela Mackie
  • 0141 847 0319
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Quality Specialist - Newhouse, Lanarkshire

Do you have previous experience in quality assurance (QA) within the biopharmaceutical industry?

Can you perform well in a fast paced environment? Can you work well in a team and also independently on your own initiative?

Do you appreciate strong Company values? Then you will fit in well with our client - Sartorius Stedim BioOutsource Ltd.

On behalf of our SRG are looking for outstanding individuals who want to make an impact in a new exciting business area and can work effectively to deliver targets, manage by example and drive standards.

Sartorius Stedim BioOutsource Ltd is the world's fastest growing provider of contract testing services to the biopharmaceutical industry. Their core offering includes a wide range of GMP, GLP and GCP tests to support Biologics and Vaccines therapeutics from their development to release into the market. They have recently built a new innovative manufacturing facility to deliver cell banking services and become the showcase facility for Sartorius products.

SRG are looking for a Quality Specialist to be involved in the maintenance of GMP complaint Quality Management Systems, maintaining Quality metrics and ensuring continuous improvement.The successful candidate must have experience in applying to EU and US GMP regulations in a similar Quality position as well as the ability to influence without authority.

In return our client can offer you a competitive salary, a generous benefits package, full on the job training, and significant opportunity for personal growth and development within a rapidly expanding successful CRO.

What you can look forward to achieving:

  • Assisting in creation and maintenance of a GMP compliant Quality system including writing and approval of compliant documentation
  • Providing advice and approving equipment qualification and process validation requirements according to GMP requirements
  • Performing internal audit functions
  • Assisting in hosting regulatory (MHRA, FDA etc.) and client inspections
  • Review and approval of batch records, batch certificates and associated documentation prior to issue to the client
  • Performing supplier assessments and assisting with supplier inspections
  • Assessing impact of deviations and providing guidance, support and co-ordination of CAPAs
  • Co-ordinating any client and supplier related quality issues
  • Preparing and delivering GMP training and providing advice on compliance issues

Skills and experience that you need to bring to the Company:

  • A degree in a relevant scientific discipline
  • Extensive Quality experience, within a GMP environment
  • Thorough understanding and experience applying EU and US GMP regulations
  • Extremely organised approach is required coupled with the ability to influence without authority
  • Excellent written and verbal communication skills coupled with the ability to prioritise multiple tasks and have the confidence to challenge existing systems & processes
  • Competent in Word, Excel and PowerPoint

This is a great opportunity to be part of a modern, dynamic business and would offer the right person excellent career development opportunities.

Please apply online or contact Pamela for further information.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

21/12/2018 09:34:24