Change Management: Change Control process
- Management of change requests, approvals, implementation, communication, distribution of information.
- Manage, coordinate and follow up changes.
- Perform /initiate change risk analysis.
- Trigger customer communication work-flows, collect information.
- Related document management (SOP, forms, checklists).
- Site risk assessment coordinator.
- Process FMEA responsible.
- Leading risk assessments, coordinating teams.
- Related document management (SOP, forms, risk management tools).
Validation & Qualification
- Equipment qualification according to “V” model: DQ, IQ and OQ.
- Equipment validation as per PQ / PV.
- Participation in projects, being responsible for qualification and validation activities.
- Create validation / qualification document, assign targets for qualification / validation activities.
- Maintenance of validation master program.
Required education and experience
- Engineer, manager or natural science degree (preferred mechanical engineer, technical manager, field of quality engineering)
- 1-3 years quality / testing experience in manufacturing industry (preferred in GMP environment)
- fluent English, good coordination skills
- MS Office, technical writing skill
- Advantages: knowledge of ISO 15378 / GMP and validation / qualification / change- and risk management experience
- Vas county
Please send your CV to firstname.lastname@example.org