Office Location: Toll City
- Preparation and execution of validation protocols (VP, URS, DQ, IQ, OQ, PQ, SR) on Instruments, Equipment, Processes in accordance with current industry standards and guidelines (GMP, GDP, GDocP) for the qualification and validation of manufacturing systems and supporting processes.
- Preparation and execution of validation protocols on Computer Systems (VP, URS, DQ, IQ, OQ, PQ, SR) in accordance with current industry standards and guidelines (GMP, GDP, GDocP) for the qualification and validation of manufacturing systems and supporting processes.
- Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects.
- Investigate and document all validation related deviations and initiate cause analysis.
- Identify necessary internal and external resources for completion of validation projects.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Generate thorough written reports, when required, that summarize engineering studies performed for feasibility evaluation.
- Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements and independently contributes to the development of new internal validation standards.
- Execute revalidation when needed.
- Execute calibration/verification activities where required.
- Develop and write SOPs systematically, logically and accurately.
- Provide training to relevant personnel on procedures.
- Champion and maintain quality standards throughout the organisation.
- Plan and assign priorities to ensure critical projects meet required deadlines.
- Administrative duties as assigned by Validation and QA Engineering Manager.
- Diploma / Bachelor degree preferably in science or engineering
- Minimum of 2 years direct validation experience in a pharmaceutical, biologics, medical device or FDA related manufacturing facility or 3PL facility is preferred.
- cGMPs, FDA regulations,
- GAMP (Good Automated Manufacturing Practice)
- MS Office
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