QA Validation Engineer
ND Reference : JDKR1712090.01QAV
Position available with No Deviation Pte. Ltd. supporting a project in South Korea
- Review and/or approve Protocol Exception and Change Request
- Prepare, execute and/or support verification and validation documents
- Manage equipment validation related documents in accordance with client’s operating procedure.
- Review and/or approve executed equipment/process validation protocols/reports
- Prepare, review and/or approve validation summary reports.
- Initiate and/or support Deviations, Change Control and CAPA
- Support commissioning and qualification execution for thermal mapping of terminal sterilizer and/or other related systems/equipment.
- Initiate, investigate and/or resolve any exceptions pertaining cleaning verification/validation execution.
Considerations / Requirements:
- A degree in Engineering or Science disciplines
- At least 3-5 years’ relevant experience working specifically in the pharmaceutical industry
- Demonstration of good team management skills
- Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
- Proactive, self-starter and capable of working alone or in a team environment
- Good knowledge of cGMP, GDP and ICH Q10
- Knowledge of ASTM 2500E risk-based approaches
- Aware of relevant guidelines for the above systems
- To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
- Be IT literate and familiar with Microsoft office suite of applications
- Proven track record in following and promoting Safety in all aspects of your role