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A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
- Position Information
(Senior) QA Specialist
- Job Description
This position is responsible for the management of quality operation of GMP Facility and Biodevelopment Lab, to ensure the operation meeting the quality requirements from customer, cooperate and regulatory. The position also focuses on establishment and improving quality culture in GMP Facility and Biodevelopment Lab.
Internal to BioVV APAC: work in liaison with all operation teams of GMP Facility and other quality team members.
External to BioVV APAC:
Within group, work with other necessary teams including but not limited to regulatory, quality teams of other functions and overseas global quality teams.
Outside group: collaborate with customers, regulatory authorities and suppliers, if necessary.
Who you are:
- Main Responsibility
Management of deviation, change control and CAPA to guarantee the compliance and effectiveness of the procedures
Act as production or development counterpart to give quality support on daily operations
Storage management of drug substance, cell banks and retention samples
Provide regulatory support in field of quality system and quality operation as per the request of customer or colleagues
Lead and act as the Subject Matter Expert of quality system and quality operation for audits and client communication
Accomplish other tasks assigned by line manager
Respect and follow EHS rules
- Autonomy and Substitution
Can be replaced:
Functional Area: Commercial
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html