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QA Specialist - Contract

Title : QA Specialist - Contract profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW119949
Contact : JP O'Connor
Office : Cork
Tel : 021 201 9097
Email : jpoconnor@careerwise.ie

Job Description

A QA Specialist is required by CareerWise Recruitment for a 2 year contract with our Cork based biotech client. Please contact Brian Flynn (Executive Search) for more information.

Role of this position

  • 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.
  • For biopharma supporting role, provide support to the QP for batch certification of Biotech drug substance materials OR for pharma supporting roles, perform batch disposition activities (API material)
  • 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.

JOB REQUIREMENTS

  • BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline
  • Ideally a minimum of 3 years QA experience.
  • Strong analytical and technical skills.
  • Problem solving skills – resolution and prevention measures.
  • Ability to network internally and externally to benchmark processes/systems

Please call JP O'Connor today for further information on 021 201 9097 or email: jpoconnor@careerwise.ie

IN SEARCH OF EXCELLENCE
Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999

 

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Careerwise Recruitment



QA Specialist - Contract

Title : QA Specialist - Contract profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW119949
Contact : JP O'Connor
Office : Cork
Tel : 021 201 9097
Email : jpoconnor@careerwise.ie

Job Description

A QA Specialist is required by CareerWise Recruitment for a 2 year contract with our Cork based biotech client. Please contact Brian Flynn (Executive Search) for more information.

Role of this position

  • 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.
  • For biopharma supporting role, provide support to the QP for batch certification of Biotech drug substance materials OR for pharma supporting roles, perform batch disposition activities (API material)
  • 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.

JOB REQUIREMENTS

  • BSc (Hons) Micro, Engineering, Biochemistry, Chemistry, Analytical or a related discipline
  • Ideally a minimum of 3 years QA experience.
  • Strong analytical and technical skills.
  • Problem solving skills – resolution and prevention measures.
  • Ability to network internally and externally to benchmark processes/systems

Please call JP O'Connor today for further information on 021 201 9097 or email: jpoconnor@careerwise.ie

IN SEARCH OF EXCELLENCE
Specialists in the recruitment of Senior Management, Operations, Technical/Engineering, Senior Supply Chain & Quality personnel, Supporting Business Demands & Growth since 1999

 

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  • Gilead

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