QA Specialist

Posted 30 Jun 2022

Shanghai, Shanghai - China

Req Id 251054

Details

 

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.

 


Your role:

  1. Position Information

Title

(Senior) QA Specialist

Department

BioVV APAC

Report to

QA Manager

Location

Shanghai

 

  1. 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:

  1. Main Responsibility

Management of deviation, change control and CAPA to guarantee the compliance and effectiveness of the procedures

  • Cooperate with other teams on necessary assessment, investigations, planning, action definition and follow up.
  • Work as coordinator in TrackWise to follow up execution of deviation, change control or CAPA.
  • Maintain tables and draft annual report if necessary.

 

Act as production or development counterpart to give quality support on daily operations

  • Communicate with operation teams regularly and align operation priorities with quality considerations.
  • Provide quality guidance to ensure operations are in compliant with quality requirements.
  • Discover opportunities for improvement and detect events will potentially harm the benefits of BioVV APAC.

 

Storage management of drug substance, cell banks and retention samples

  • Maintain tables and perform regular stock check with operation team.

 

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

 

  1. Autonomy and Substitution

Autonomy:

  • Autonomy in the daily quality operations management of GMP Facility and Biodevelopment Lab within defined responsibility.

Can be replaced:

  • Completely by QA Manager.
  • Partially by a peer Senior QA Specialist or QA Specialist.

 

Can replace:

  • Partially of the QA Manager on quality topics.
  • Partially by a Senior QA Specialist or QA Specialist.

 

 

  1. Qualification

Education

  • Bachelor’s degree or above;
  • Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds

 

Experience

  • 3-8 years+ of working experience in pharmaceutical, bio-pharmaceutical or life science industry
  • 2-5 years+ working experience of quality related fields (e.g. QA, etc.)
  • 5 years+ working experience in GMP or GLP environment is a plus
  • Ability of regulatory precipitation
  • Knowledge of antibody production process is a plus
  • Successful project participation experience of establishing PD/GMP QMS, C&Q or NMPA/FDA/EMEA GMP certification
  • Participation experience of customer project

 

Language Skill

  • CET 6 or equivalent certification of English
  • Fluent English reading and writing
  • Fluent English speaking is a plus

 

 

HR: 87157

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

Apply Now