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Job Details

Quality Assurance Product Specialist

Company: Clinical Professionals Ltd
Location: Buckinghamshire
Reference: JO-1810-417727
Closing Date: 29 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

We are looking for a Graduate Quality Assurance Product Specialist to provide QA support to the manufacture of products commercialised within any of our Clients group of companies.

Requirements:

Quality Assurance Product Specialist (Trainee) – Fluent Japanese

Permanent
Buckinghamshire, UK
Competitive starting salary and benefits package

We are looking for a Graduate Quality Assurance Product Specialist to provide QA support to the manufacture of products commercialised within any of our Clients group of companies.  To ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements. 

 

Key Responsibilities: 

You will write/ interpret / translate / review key GMP and technical documents and ensure compliance with EU and US GxP requirements.

 

Key Responsibilities:

  • A Life Science degree or equivalent preferably in biochemical process technology or advanced biochemical /chemical analytics.
  • Fluent in the technical aspects of both the English (written & spoken) and the Japanese (written and spoken) languages is key to this role.
  • Some experience or understanding of the requirements of working within the pharmaceutical industry, specifically within a quality management position at a sterile products/biologicals manufacturing site.
  • Solid basic knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
  • Sound knowledge of QC and Stability chemical analytical testing techniques for Steriles / biologics
  • Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
  • Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines

  

If you meet the outlined requirements and are interested in this position, then please feel free to send your CV to stephen.wincott@clinicalprofessionals.co.uk or if you have any questions regarding the role then please call 0118 959 4990.

Apply for this job: Quality Assurance Product Specialist

Contact Information:

Address:  Clinical Professionals Ltd
33 Blagrave Street,
Reading
RG1 1PW
England
Tel:  0118 959 4990
Fax:  0118 956 0607
Website:  Visit Our Web Site

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