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About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

Job Responsibilities:

-As Part of Boehringer Ingelheim international network, proactively link with the other Boehringer Ingelheim sites to exchange best practice and bring up the overall competencies with in Boehringer Ingelheim China and other Boehringer Ingelheim sites. Drive, deliver and transfer the organization to become an innovation organization.

-Lead all flows including solid, liquid and other dosage forms to make continuous improvement on all production process EHS, Quality, Supply and Cost.

-Implement the company strategy in the whole production department

-Engage, Enable and Empower the whole production department to case cade down our company Vision, Mission, Value, and cultivate Ethic& compliance, safety, quality, AAI, Lead & Learn , Innovation, Diversity & Inclusion and Catalyst leadership culture.

-Develop the team for both leadership & professional competencies.

-As a delegated person of T&O Director：

• To ensure all production activities in line with quality & regulatory requirements.

• To approve production related procedures and ensure these procedure being followed strictly.

• To ensure products being produced and stored according to approved technological procedure, ensure the quality of products.

• To ensure all deviations are timely investigated and handled in TO department.

• To ensure all related complaints are timely and properly investigated and handled in TO department.

• To ensure batch record being reviewed by authorized people and hand over to QA.

• To ensure self-inspection in TO department.

• To ensure plant and equipment maintenance and continuously keep good operating status.

• To ensure the appropriate validations are done, and to review and approve relevant validation documents.

• To ensure that the required initial and continuing training of personnel is carried out and adapted according to need.

• Ensure the establishment and implementation of quality management system and relevant management regulations for data integrity

• Responsible that data integrity principle are applied in the course of all GMP activities within areas of responsibility.

• Responsible for establish and maintain an appropriate Quality Culture and working environment to minimize the risk of data integrity.

• Ensure that personnel are trained on data integrity.

• Accountable for the immediate report, investigation and follow up action of any data integrity issue occurring within areas of responsibility

Requirements:

-Over 10 years experience,knowledge in pharmaceutical formulation and packaging

-Extensive experience in the Production disciplines. This must include total understanding of Manufacturing and Packaging Processes, Quality Regulations and explicit understanding of CGMP，such as China, EU, Australia and other South East Asia country regulation.

-Knowledge of the recommendations of industry guidance documents such as the ISPE/GAMP guide and the associated good practice guides and understand the complexity of automation and pharmaceutical production processes.

-Knowledge on new technology of Trick&Track, and steability

-Preferred major in pharmacy or medicine

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.