The Operator Bulk Operations will be responsible for ensuring the manufacturing activities of products (capsules and/or tablets), in compliance with BPF/cGMP regulations, hygiene, and safety rules. They must adhere to the procedures defined by the pharmaceutical site's quality system.
Perform production operations such as weighing materials, preparing powder mixtures, and operating automated lines (encapsulator, tablet press, coater, automated visual inspection...) following their training curriculum and according to the procedures in force of the quality system.
Master and perform cleaning of equipment related to these different stages.
Perform line clearance, cleaning of parts, equipment, and rooms after production.
Perform basic physical controls of manufactured products.
Comply with production objectives and respect the established schedule.
Ensure the completion of industrial batch manufacturing operations in a GMP environment and work autonomously and efficiently according to the instructions of their supervisor.
Control, record, and complete pre-established work documents to ensure follow-up of operations performed (GMP filled batch dossiers).
Comply with the safety and security rules of the pharmaceutical site.
Announce dangerous situations, near misses/incidents, and accidents that could occur on the site to their direct supervisor and to the EHS department.
Initial training at CFC level and 5 years of experience in pharmaceutical production or ideally 3 years as a technician in the pharmaceutical industry.
Know the BPF/GMP environment and/or the cleanroom working environment.
Have perfect mastery of French.
Be organized and rigorous, with excellent team working abilities.
Have good basic knowledge of computer tools.
Wuxi is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.