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Job Details

QA Officer

Company: ProClinical Ltd
Location: Neuchâtel
Reference: QA.CK.10080
Closing Date: 13 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

ProClinical is seeking a QA Officer on behalf our client, a global pharmaceutical company that employs over 5,000 in 80 countries.Job Role:This QA Officer job will work with the Manufacturing, Quality Control and Development departments as Quality Assurance representative. They will be responsible for reviewing of master batch record and associated documents and the closure of deviations, change controls and laboratory investigations related to batch production. ...

Requirements:

ProClinical is seeking a QA Officer on behalf our client, a global pharmaceutical company that employs over 5,000 in 80 countries.

Job Role:

This QA Officer job will work with the Manufacturing, Quality Control and Development departments as Quality Assurance representative. They will be responsible for reviewing of master batch record and associated documents and the closure of deviations, change controls and laboratory investigations related to batch production. They will also review and approve manufacturing batch records and certificate of analysis from QC.

Job Responsibilities:

  • QA representative in NBE (novel biological entity) production projects, tech transfer, change control and deviations.
  • Ensure the review and approval of product master batch record.
  • Review and approve product specifications and standard operating procedures.
  • Support the evaluation of NBE product manufacturing related deviations, CAPA, change controls, laboratory investigation and internal audit findings.
  • Provide support for inspection by authorities, internal and external audits.
  • Contribute in the optimisation of quality processes based on GMP.

Education and Experience:

  • BSc, MSc or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline
  • At least 2 years of relevant experience in an industrial setting under GMP manufacturing conditions
  • Relevant experience in biotechnology (quality management of USP/DSP recombinant monoclonal antibody production).
  • QA experience and knowledge of current Swissmedic, EMEA, FDA, USP, EP and ICH guidelines
  • Experience in tech transfer of GMP Manufacturing process (BDS/DP) to CMO is a plus
  • Experience in change control and deviation management
  • Ability to work independently with proven experience in problem analysis/solving, anticipation and proactivity
  • Fluent English both written and verbal; proficiency in French is highly desirable

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Claudia Kirner on +44 203 0789 556 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: QA Officer

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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