QA Manager - BIO Pharma
勃林格殷格翰投资有限公司上海市 浦东新区Update time: September 15,2019
Job Description
上海市 浦东新区

Talent@Boehringer Ingelheim


About Boehringer Ingelheim

Join Boehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and have collaborated and innovated medicines in Human Pharma, Animal Health and Biopharmaceutical everywhere in the world for over 130 years. This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations.

We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve BI global Ambition 2025:

  • No. 1 in Animal Health

  • No. 1 in Biopharmaceutical Contract Manufacturing

  • No. 1 in value share for our brands in One Human Pharma


As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 6 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa.

For more information, please

  • visit https://www.boehringer-ingelheim.com/ or

  • follow us on LinkedIn, or

  • follow us on WeChat – JoinBI


About Biopharmaceutical Contract Manufacturing

As one of the world’s largest biopharmaceutical producers, 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. The Company launched its world-class Biopharmaceuticals Manufacturing Site in China in 2017 with first-phase investment of more than EUR 70 million. This site is the first and only biopharma site in line with global standards set by a multinational pharma company in China, and has become a major milestone in Boehringer Ingelheim’s strategic blueprint for its biopharma business globally.

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

  • To ensure continual improvement of processes and work flow within processes to increase the efficiency.

  • Continuous monitoring the quality KPIs and the process parameters, to improve the performance.

  • Implementation of GMP assessment & oversight in quality control, quality validation, E&T, and SLM

  • Release of the GMP area or equipment for GMP work

  • Review and approval of GMP documents such as SOPs (Standard Operating Procedures) and working instructions

  • Take the role of local management system owner to improve the local quality process, and support the revision of Biopharma Division procedure.

  • Support client regulatory CMC in compilation of response to client queries.

  • Support the site readiness for regulatory inspections, and support remediation from inspections where required.

  • Participate in internal projects as defined and support the team in achieving targets defined in BioChina Quality plan.

  • Be in charge of the change control process, ensuring that each change proposed during the project is properly defined, considered and approved

  • Monitoring/trend analysis of all changes

  • Ensure the quality and compliance of the deviation investigation, CAPA effectiveness and the OOX occurrences be thoroughly investigated and addressed

  • Perform effective deviation investigations as lead investigator

  • Customer interaction, support PM to fulfill customer needs in terms of the quality documentation requirements

  • Provide the status review on deviations and CAPAs

  • Monitoring/trend analysis of deviations and CAPAs

  • Take part in change, deviation & CAPA review board

  • Batch record review & support QP for batch disposition

  • Perform the batch analysis record review for QA

  • Perform the batch record review and support QP for the batch disposition


Qualifications

  • Education/Degree Requirements: Bachelor degree on Pharmaceuticals, Biopharmaceuticals, Analytical Chemistry

  • Language skills & proficiency: Proficient in spoken and written English

  • Required capabilities: Good communication skill and interpersonal skills, fast learning ability, self- motivated and goal oriented professional competence


Behaviours

  • Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions

  • Agility – Quickly act with an open mind to face internal and external transformation

  • Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets

Contact Us

If you think you can convince us that you are the right candidate we are looking for, please contact us at: HRTalentAcquisition.CN@boehringer-ingelheim.com


职能类别: 质量管理/测试经理(QA/QC经理)

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