|Client; Medical Devise and Equipment manufacturing company.
Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports.
- Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
- Review and Approve validation protocols and assessments from a quality system documentation perspective.
- Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues.
- Participate and communicate as required in project activities.
- Develop procedures to manage computerised systems where required
- Develop and present project plans to project management senior staff
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMP’s and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills
- Understanding of the computer system validation lifecycle
- Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards.
- The successful candidate will have a least 3 years experience validating IS Automation systems for manufacturing organisations in the biotechnology or pharmaceutical industries.
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