職位描述
職位描述：
Description:
The QA Specialist- Aseptic Filling is responsible for supporting the build-up of the aseptic filling line at Biopharma China OASIS manufacturing site, include Formulation, aseptic filling,, capping, and inspection) and providing oversight for future aseptic filling activities as well as Aseptic filling CMO (If have) management.
-Provide support to the filling line built-up from Quality’s perspective.
-Interface with 3rd party filling CMO, work as QIP (quality in plant).
-Oversight deviations, change controls and CAPAs, batch release sub team member.
-Perform quality reviews and approve maintenance work orders and .instrument calibration assessments.
-Review, Author & Revise Operations SOPs and Maintenance SOPs.
-Work with operations, maintenance, quality, and engineering teams on quality improvement projects or corrective actions.
Duties & Responsibilities:
?Provide quality support to the built-up of the aseptic filling line.
?Coordinate filling activities take place at 3rd party CMO, ensure adherence to the agreed-upon filling timeline.Provide on the floor support at 3rd party CMO as Quality in Plant.
?Provide overall coordination on deviations, change controls and CAPAs, contribute to batch release activities.
?Perform quality reviews and approve maintenance work orders and instrument calibration assessments.
?Review, Author &/or Revise Operations SOPs and Maintenance SOPs.
?Work with operations, maintenance, quality, and engineering teams on quality improvement projects or corrective actions.
Requirements:
?Bachelor or Master degree in Bioengineering, Chemical Engineering, Biopharmaceuticals, Biochemistry, Biology, Biotechnology, or Pharmacy
?2-5 years working experience for similar position at MNC company with aspetic product, either in QA or production
?Deep knowledge on the state of the art aseptic filling technology and regulatory requirements
?Committed excellent team player
?Strongly goal orientated
?Excellent communication
?Fluent Chinese and English
Our Culture:
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit http://www.boehringer-ingelheim.com/
