QS Manager 1
Boehringer IngelheimChinaUpdate time: September 3,2019
Job Description
QS Manager 1-1910417
Talent@Boehringer Ingelheim
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.
Job Responsibilities
- Achieves quality system operational objectives by contributing information and analysis to quality system processes; preparing and completing agreed-upon action plans.
- Maintains and improves Quality system by being pro actively identify system or individual issues and/or by supporting/leading corporate, internal, client and authority audits.
- Maintain and improve ORI system in BioChina as needed to proactive ensure BI and authority regulation compliance
- Precisely execute QS operational tasks according to the agreed upon execution plan and time lines.
- As key owner of BioChina compliance system to establish ORI system and build standard way to host "audit/inspection" by authority and client. (e.g. moderation during inspections/audits, support timely preparation of inspection/audit requests and lead the process of response procedure and support SMEs to fulfill inspection/audit requests until mitigation action execution, etc. )
- Support Quality system head to execute the site inspection readiness activities.
- Lead the establishment and execution of the E2E self-inspection program to ensure the program drives continuous improvement of the site’s systems, processes and operational performance
- Work closely with all internal auditors to continuously optimize the self-inspection process, to support the self-inspection mechanism being built up and implemented in other functions within the site to ensure the self-inspection plan is sound established, fully executed and potential compliance risks be identified and mitigated.
- Maintain and consciously improve internal auditor pool and qualification.
- Assure quality compliance for all GMP manufacturing relevant activities; Provide support to other department interfaces from the GMP perspective under CFDA, FDA, EU and ICH guidance and BI internal guidance.
- Support the engagement in the interaction with the HA as needed.
- Provide active oversight and monitoring Bio China monthly quality system performance by QMR preparation and monthly KPIs generation
Maintain SMF by consolidating the information provided by functional department.
- Continuously and pro actively acquire knowledge from daily tasks, trainings and BI global net works. Complete newly/other assigned tasks as per regulated by line manager.
Qualifications
- Education/Degree Requirements: Bachelor or Master's degree
- Major: Focus on Pharmaceutical/Biophamaceutical, Biotechnology, Chemistry/Biochemistry
- Language skills & proficiency: fluent English in aural and oral, reading and writing
-Familiarity in CFDA & international regulations related to pharmaceuticals. -Familiarity in other international guidelines (e.g. ICH, PIC/S, WHO, etc.)
- Strong expertise in QS and HA inspections; Planning and executing audits/inspections (including self-inspection).
- Practical experience and oversight of QS owned processes
years of working experience in quality related department in pharmaceutical industry.
- Familiar with Biological production process (preferred) and quality system.
- Required capabilities (skills, experience, competencies)
- Minimum 5-10 years of general experience in the pharmaceutical industry with direct experience in a cGMP manufacturing environment. 3-5 years experience in a quality systems or process/continuous improvement role.
- Comprehensive knowledge and understanding of regulatory QS requirements as governed by cGMP and regulatory agencies (CFDA, USFDA, EMA, etc.)
- Proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
- Excellent communication skills, persistence, commitment
- Rapid learning ability, high level of energy and self motivation
- Inter-cultural competence, be culturally sensitive and diplomatic
- Ability to work independently and flexible
工作 - 生物制药
主要地点 - Africa, Asia, Australasia-中国
组织 - 勃林格殷格翰生物药业（中国）有限公司
编制 - 全职
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