QA Specialist - Clinical/Analytical Quality Assurance

Hampshire  ‐ Onsite
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Keywords

Description

Job Duties

To provide QA support for the manufacture, packaging, labeling, and control of clinical trial materials manufactured by Shire contractors to ensure compliance with GMP requirements. To provide QA support for the analytical performed at contract laboratories for commercial and developmental/clinical use. To perform GMP release of IMP and ensure compliant release to global markets as appropriate.

Job Duty and Description

To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and CTA requirements. To review and approve master records labels and protocols. Actively participate in project meetings as required. To be knowledgeable about the products supplied for clinical trials.

To ensure that all appropriate batch related documents and finished packs are available from contractors/suppliers in order to enable release of products. Provide GMP certification/release of IMP ensuring global compliance.

To participate in the QA auditing programme of contractors/suppliers to ensure compliance with GMP and be knowledgeable about the main contractor sites used by XXXX to provide IMP and those performing analytical work on behalf of XXXXX. To support and maintain the relevant Technical Agreements.

To communicate with contractors/suppliers regarding technical information and queries. Ensure deviations/OOS are adequately investigated and documented. Ensure clinical complaints are adequately investigated and reported.

To ensure that the documentation systems to support Clinical/Analytical QA activities are maintained. To prepare and/or update standard operating procedures and to ensure all Clinical/Analytical QA SOPs are reviewed in a timely manner. To participate in the GQA self-inspection programme concerning clinical GMP areas as appropriate.

Experience/Education Requirements

  • University degree or equivalent in Chemistry, Biology, Pharmacy or other relevant science or an equivalent combination of education and experience - required
  • Practical Experience of at least 8 years in a QA environment in the pharmaceutical industry - required
  • Practical clinical manufacturing/packaging/labeling environment experience - required
  • Practical experience with manufacturing of solid dose pharmaceutical products - required
  • Experience auditing clinical solid dose manufacturing, packaging, and labeling contractors - required
  • Good understanding of GMPs within a global environment - required
  • Good understanding of method development and validation, specification setting - preferred
Start date
n.a
Duration
6 months initially
From
Scope AT Limited
Published at
04.10.2012
Project ID:
429466
Contract type
Freelance
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