QC验证主管岗位职责

QC Validation/Qualification Supervisor仪器验证主管 诺化仕(无锡)制药有限公司 诺化仕(无锡)制药有限公司,诺化仕,诺化仕 Job Summary:

•Ensure the maintenance and qualification of the analytical and metrological equipment of the Novacyl Quality Control Laboratory;

•Support non-routine analytic activities such as Analytical validation, Analytical transfers and Method troubleshooting;

•Manage the analysts in charge of Qualification and validation activities (resources from the HPLC and physical chemistry laboratory seconded to the Qualification/validation projects).

Mains missions :

•Maintenance/Qualification of laboratory equipment ;

•Management of analytical transfer and validations.

Mission 1: Maintenance

? Organizes the preventive maintenance (internal or external) and the periodic verifications (internal or external) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs

? Organizes the curative maintenance of laboratory equipment during breakdowns (internal or external) (planning / monitoring of service providers)

? Manages stocks of spare parts needed for first-level maintenance

? Represents the maintenance pole during audits and inspections by the authorities

? Supports laboratory technicians in case of equipment problems

? Organizes calibration/verification of standards dedicated to equipment verification by external agencies

Mission 2: Qualification Laboratory Equipment

? Write the equipment qualification documentation for the laboratory (URS, protocols ....)

? Organize qualification by suppliers

? Conduct and / or organize additional tests not performed by suppliers (internal or outsourced)

? Write the equipment usage documentation (operating modes, logbooks ...)

? Presents qualification records during audits and inspections by the authorities

? Ensures the training of technicians in the use of equipment

? Organizes equipment supplier qualification

? Participates in the choice of laboratory equipment and software

Mission 3: Coordination of analytical transfer, validations and troubleshooting activities

? Supports the technicians in case of analytical problem, technical OOS, technical question ? Write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) ? Organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)

? Participates in the creation / modification of the working documentation (analytical methods, work instructions…

Mission 4: Laboratory life

? Participates to various meetings related to the operation of the service (daily, monthly ...) ? Leads actions to improve the operation of the maintenance center and the laboratory. ? Defines with the manager the investment strategy for laboratory equipment ? Is the system administrator of the lab's SI

Required skills:

1. Bachelor degree in relevant;

2. With 5-10 years professional experience in a Quality Control laboratory in a GMP environment;

3. Spoken English is a plus;

4. Good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ICH...);

5. Good understanding of equipment and analytical laboratory techniques (Titration, GC, HPLC, Spectroscopy, Karl Fischer, ....);

6. Knowledge of software related to laboratory equipment.