Responsibilities:

• Responsible for the production operations to ensure that safety, quality and productivity goals are met in compliance with EU, US FDA and CFDA requirements as applicable.

• Creates the Annual Validation Master Plan and then oversees its execution. Validation of processes and cleaning, and qualification of both new and existing equipment. Ensures all is executed in accordance with company procedures and regulatory expectations.

• Owns departmental SOPs and equipment. Converts the Master Schedule into the Production Schedule. Provides, updates and manages towards showing minimization and optimization of production costs.

• Sets departmental cross-training and performance expectation and coaching subordinates to ensure operational compliance.

• Accepts responsibilities for deviation, changes, root cause analysis and quality departmental improvements.

• Work with product development to solve difficult technical problems and coach manufacturing personnel in solving technical problem.

• Other tasks assigned by Manager.

  Qualification and Job Requirements:

• Have experience in EU and US FDA inspection.

• Bachelor degree or above in pharmacy or related field.

• Rich experience in management of final handling workshop or clean area in pharmaceutical enterprises.

• Ability to communicate, coordinate and cooperate.

• Good English listening, speaking, reading and writing skills.

上班地址：椒江