QA Rep

Cork  ‐ Onsite
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Description

Global Biotech Company based in cork is currently seeking a QA rep to join their QA team.

Responsibilities
  • Provide Quality leadership, direction and governance for the specific area of responsibility
  • Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence in the area of responsibility
  • Approval/review of batch records.
  • Provide support to the QP for batch certification of Biotech drug substance materials
  • Review and approval of Trackwise change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
  • Review and approval of GMP documents associated with qualification and validation including, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes
  • Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
  • Approval of raw materials, intermediates and packaging components used in the manufacture of pharmaceutical products, using SAP
  • Evaluation, audit and approval of 3rd party vendors of raw materials, intermediates and packaging components.
  • Participation in internal and external audits
  • Communication and education of personnel in GMP requirements and regulations.


Basic Qualifications

BSc Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline with a minimum of 3 years QA experience.
  • Previous experience in a biotech GMP production environment essential, preferably in a quality role or a relevant technical support role.
  • Strong analytical and technical skills.
  • Problem solving skills - resolution and prevention measures.
  • An excellent teamwork approach.
  • Guidance of others through processes.
  • Very strong communication and people skills - interaction with production, engineering, suppliers, other sites.
  • Flexibility to change.
  • Ability to network internally and externally to benchmark processes/systems


If you are interested in this role please contact me Anna Mooney or apply below with an up to date CV.
Start date
04/2016
From
Real Staffing
Published at
24.02.2016
Project ID:
1077783
Contract type
Permanent
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