To assist with the equipment qualification from the backlog (PNS lab expansion qualification) and Data Integrity equipment replacement.
- Preparation of validation documents, including URS, PS, validation plan, IQ/OQ/PQ protocols and reports, validation reports and traceability matrix
- Perform ERES assessment as per site procedure
- Arranging, planning, managing and executing installations, operations and performance qualifications of laboratory systems
- Coordinating and interfacing with department, validation team, vendors and engineering groups for assuring successful project execution.
- Leading and coordinating cross-functional teams for project validation
- Priorization, managing and executing multiple projects utilizing the project management methodologies
- Prepare equipment standard operating procedures
- Min 4-5 years of relevant past experience is a must.
- Candidate must have had the experience of working in a GNP/GLP environment, preferably from a pharmaceutical, biopharma or lab background
- Knowledge of the various regulatory pharmaceutical validation requirements and technical laboratory equipment qualification knowledge preferable
- Strong command of written and spoken English
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | Fiona Koh | Registration No: R11092398
Contact Person: Koh, Fiona - Reg No:R1109239 (firstname.lastname@example.org)