(Sr.) QA Scientist

About Biopharmaceutical Contract Manufacturing

Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.

Responsibilities

1. End to end GMP Duties & Oversight on GMP activities of assigned GMP areas(e.g: DS area, QC testing related to DS)

• Implementation of GMP assessments & oversight in assigned GMP areas.

• Review PD, MBR, Specification, Analytical procedure and other GMP document.

• Approve operational level SOPs/ Qualification documents

• Participation for audits as well as support of the experts in answering audit findings

2. MSO(Management System owner) & local SOP owner

• Keep improving system quality and attainability.

• Provide training to system users.

• Aligning with BI global/ BI bio procedures and authority guidance, e.g. FDA, NMPA, EU, ICH, etc.

• Participate in the audit as the system owner/SOP owner as well as answer audit findings.

• Take the role of assigned local management system owner and/or local SOP owner to continuously improve the local quality management system, and support creations and revision of Biopharma Division Procedure.

3. OOX/Discrepancy/CAPA/Complaint/Investigation

• Ensure that the quality aspects of the OOX/ Discrepancy /CAPA/Complaint/investigation comply (contents, clarity, completeness).

• Support the investigation team.

• Participation in Deviation & CAPA board

• Prepare and distribute status reviews on Discrepancy/CAPA/Investigation.

• Plan and carry out effectiveness check of CAPA.

• Monitoring/trending of Discrepancy

4. Change Management

• Ensure that the quality aspects of the change requests comply (content, clarity, completeness)

• Support for submitting the change request

• Release of the change request for implementation

• Definition and implementation of Effectiveness checks

• Support the change and follow up the timely closure of change

5. Batch Record/Analysis Reports/GMP Documents Review

• Carrying out DS Batch Record and Analysis Reports Review.

• Oversight GMP documents generation e.g. SOPs, MBRs, Risk Assessment etc.

• Responsible for answering customer comments during BR and Analysis Reports review, coordination with the experts.

6. Processes/ BPE

• Ensure continual improvement of processes and work sequences within processes and for the interfaces

• Continuous critical review of the respective Status Quo regarding the diverse KPIs and the process parameters, to improve our daily work sequences

• Participation as project leader, core team member or expert in the various Streams/Initiatives

7. Work within QA management to contribute to other QA related work packages, e.g. qualification, Training, per business needs.

Qualifications

• Bachelor degree on Pharmaceutical, Biopharmaceutical, Chemistry, Analytical

• At least 8 years of experience working in a GMP8environment; experience in Quality Assurance is preferred.

• Language skills & proficiency: Fluent in reading, and good in spoken and written.

• Good GMP regulation expertise include FDA, EMA and NMPA

• Biological production and QC knowledge include cell line technology, USP and DSP, mAb manufacturing, aseptic product manufacturing and test knowledge; GMP regulation expertise includes FDA, EMA and NMPA- Excellent communication skills, persistence, commitment.

• Rapid learning ability, high level of energy and self-motivation.

• Ability to work independently and flexibly.