CLIENT PROFILE
Our client is an MNC pharmaceutical company which builds green field projects in Beijing. The role is a long-term role directly hired by the company.
Job Responsibilities
- Lead the C&Q team (system leaders, per workstream / group of systems).
- Design C&Q detailed approach as per C&Q project plan, for all systems (GxP and non-GxP).
- Coordinate C&Q work with engineering contractors for C&Q topic and all disciplines within organization.
- Ensure all C&Q documents are on time including FAT/SAT documents.
- Lead and manage deviation process and ensure deviation are closed on time with all expected documents.
- Provide support to project change, engineering change and technical change assessment with regards to C&Q part.
- Prepare transition after OQ/PQ with MSAT and Operations.
WHAT WE EXPECT OF YOU
- Bachelor or above in Process Engineering, Mechanical Engineering, Automation or related.
- 10+ years of solid experience of commissioning and qualification in pharmaceutical production environment, greenfield/brownfiled project and/or operational facility.
- Experience in leading and managing teams directly and indirectly.
- Experience in working in a large, complex matrixes environment with global processes and governance structures.
- Good knowledge of regulatory requirements such as cGMP, FDA.
- Fluent English language skills, both written and verbal