Job Reference: J563113
Updated On: 16/10/2018
Status: Open to Applications
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Role OverviewAn exciting opportunity for a QA Equipment and Validation Specialist to join a leading company based in the Hertfordshire area has become available. As the QA Equipment and Validation Specialist you will be responsible for advising all Validation personnel on the GMP guidance and legislation to ensure the site is in a compliant state.
Key Duties and ResponsibilitiesYour duties as the QA Equipment and Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will critically review and approve maintenance and validation documentation for the facility on behalf of QA to ensure compliance with GXP requirements.
2. You will critically review and approve process validation documentation on behalf of QA to ensure compliance with GMP requirements.
3. You will work closely with Engineering and Validation to support compliance documentation and keep to current GMP guidance and legislation.
4. You will act as a QA representative as required at project meetings or working parties on the modification or replacement of key manufacturing equipment or Utilities.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Equipment and Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or Engineering related discipline.
2. Proven industry experience in reviewing or writing validation documentation within a Pharmaceutical environment.
3. A working knowledge and practical experience with GMP/GEP regulations, sterilisation validation, autoclave and freeze dryer validation.
Key Words: QA | Equipment Validation | Documentation | Quality Review | Manufacturing | Pharmaceutical | GMP | GEP | Autoclave | Sterilisation | Engineering | Quality | Compliance |
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