Tasks:
- Is responsible to create and follow up the required change notifications/CRF.
- Is responsible for defining and executing the engineering tests, verification and validation of assigned equipment.
- Defines the validation approach, creates test protocols for engineering tests, creates verification and validation documents, executes tests, coordinates SME and system owner approvals.
- Is responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions).
- Supports other validations (ECO, SMC, batch records) executed by other departments.
- As responsible for the CRF, the PE will support the registration process in relation with site compliance if required.
- Supports documentation of technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant PE/SME.
- Good documentation skills, able to deliver clear and complete documents
- Good communication skills
- Pragmatic, pro-active, can take the lead
- Results focused
- Able to work independently but is also a team player
- Experienced in planning and project coordination (MS Project is a plus)
- Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
- Hands-on and good problem solving skills
- Shows ownership
- An interesting salary package
- A dynamic and high-tech life sciences environment
Sophie Steels
https://ift.tt/2CaMYKa
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