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

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!