대전 바이오 공장 신설 - QA Specialist (5년 이상, GMP, ISO)

Posted 08 Apr 2024

Daejeon, Daejeon - Republic of Korea

Req Id 273396

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.


Your role:
 

Overall Objectives of the Position

  • The Quality Assurance specialist will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory (ISO, EXCiPACT and applicable agencies), internal standard and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.
  • The Quality Assurance specialist will handle to Documentation System, Production Quality, Training System building-up and operation to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.
  • The Quality Assurance specialist will conduct audits of manufacturers, laboratories, supplier, etc. to assure compliance to current standards/ISO. And resolve quality concerns and implement quality improvements by meeting with other department Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards.

 

Responsibilities

  • Check production line daily and control for the whole production process to ensure the whole production process control can meet with site procedures.
  • Prepare the quality related procedure according to company requirement.
  • Prepare the SOPs for quality management system (Document, Deviation, CAPA, Change control etc..)
  • Review and approve the SOPs
  • Build up the quality related electronic systems
  • Participate in GMP training program in the plant to ensure the training management meeting the requirements of site and global.
  • Review the validation and qualification document and Investigation of quality issue
  • Deviation/change control management
  • Annual product review
  • Ensure to fulfill the KPIs of QA
  • Actively participate in quality culture building and quality related activities
  • Actively report quality related events and participate in continuous quality improvement activities.
  • Manage all quality audit aspects of Suppliers, Repackagers, Distributors, Warehouses, Contract Laboratories as appropriate and timely provide audit report and supplier CAPA, and follow up supplier CAPA until the final audit

 

Who you are:

 

Qualification:

  • Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline.
  • At least 5 years of working experience in an international pharmaceutical or biological GMP/ISO environment with GMP/ISO experience. Aseptic experience is preferred.
  • New project experience and build-up of quality management system are preferred.
  • Familiar with GMP regulations/guides and quality management process.
  • Fluent in English.
  • Result orientation, accuracy and reliability as a must.
  • Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.

 



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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

Apply Now

Join our Talent Zone

You haven't found quite the right job yet? Join our Talent Zone and stay in touch with us. Be the first one to learn about our new career opportunities and events.

Tell us about yourself and let our Talent Advisors help you find your next career opportunity.