Validation Documentation Engineer
Teleflex
- Kamunting, Perak
- Permanent
- Full-time
2. Work with SQ, RA, QA and relevant global teams to gather information and approvals for projects.
3. Arrange and conduct trainings after completion of projects as per Training requirements.
4. Prepare and Maintain site master validation plan.
5. Review validation are conducted as per protocols.
6. Support Materials Initiatives Validation Team when when needed on other matters related to project planning, execution and closure.
7. Scope - Covers all Procurement related projects for APAC sitesEducation / Experience RequirementsQualification :
Degree in Engineering, Science or Math,Experience
: Experience in ISO13485, FDA Audit, Process Validations, Change Management.
: 3-5 years experience in validation activities
: Experience in IQ,OQ and PQ testing requirements
: Some knowledge about Regulatory Authority requirements
: Knowledge on MDD and MDR
: Has worked on Master Validation Plan
: Has experience in conducting training on validation and quality related matters
: COF & CRF issuanceSpecialized Skills / Other RequirementsNote: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.Teleflex is an equal opportunities employerTeleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.