QA Specialist

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.

Accountabilities:

• Collect, submit & coordinate Corporate CRC
• Maintain and manage the change control system and ensure the change management is under control.
• Evaluate and coordinate the change project to ensure the project execution complied with plan and regulation
• Maintain and manage the change control system and ensure the change management is under control.
• Evaluate and coordinate the change project to ensure the project execution complied with plan and regulation
• Follow up regulations including Chinese GMP，EU，TGA，PIC/S, ICH etc.
• Communicate with channel to maintain with authority，association etc.
• Maintain license and certificate in fully compliance status.
• Review and collect updates of regulations/guidelines such as NMPA, ICH, PIC/S, etc. and conduct gap analysis timely.
• Conduct gap analyses of the regulatory to ensure comply with regulatory requirement; 
• Ensue registration documents and CMC documents are right first time and well maintained.
• Prepare, receive and response to corrective measures of external audits, maintain and optimize and external audit process to continuously improve the effectiveness and efficiency of quality management

Requirements

• Experience in similar role, prefer with Pharma operation/multinational background or experience
• Good knowledge of GMP 
• Good specific knowledge relevant to job
• Good PC skills in Excel, PowerPoint and Word
• Good English language skills, both verbal and written
• Good at communication and team work spirit.
• Customer service focus and understanding of clients’ needs
• Adaptability to change, willingness to share and learn
• Good analytical and scientific thinking and problem solving skills
• Result oriented