담당업무

ㆍ1.      Improve processes base on ISO 9001, ISO 22000, ISO 13485, FDA, Pharmaceutical and Biotechnology standards, practices and previous knowledge and experience.

2.      Develop, implement and report the internal quality system audit and mock audit program with Division personnel against ISO 9001 and Halal.

3.      Participates the audit processes, both internal and external (customer, certification and regulatory bodies) to identify opportunities for continual improvement.

4.      Provide support for the control of national and international standards library to ensure that the most up to date revision is always available at the point of use.

5.      Implements performance measurements necessary to effectively evaluate organizational performance and trends in product quality, service, RPPM, COPQ and customer satisfaction. Uses the results of performance evaluation and audits to target improvement efforts.

6.      Carry out or complete any activities required to support the needs or requests from customers and regulatory authorities. For example, audits, questionnaires, agreements, etc.

7.      Quality & Customer Interface: Maintains system a corrective/preventive actions to analyze and correct nonconforming conditions and complaints.

8.      To review a plan of change controls and verify its changes with the necessary objective evidence.

9.      Validation: Develops validation plans and protocols for the qualification and validation of existing and new equipment, manufacturing processes and products. This could extend and link into facilities, utilities, cleaning and software.

10.    Provide necessary support to make sure the effective running of manufacturing site/Laboratory calibration, maintenance and training systems.

11.    Provide quality management software systems, regular cGMP training and related quality training to all relevant employees across the site as needed.

12.    Provide support and guidance as needed for the cleaning, calibration and pest control contractors.

13.   ISO 22000 / HACCP Certification Promotion Leader and Support / deputize other certification such as Halal.

자격요건

ㆍ학력 : 대졸이상

ㆍ경력 : 경력8년↑

ㆍ   Fluent written and verbal in English skills preferred.

ㆍ Qualifications: 4 year college degree in Industrial engineering, Chemical engineering, Biology or related department required with certification in quality management preferred. 

ㆍ 8~10 year`s experience working within a Life Sciences, Medical Devices and/or Pharmaceutical style of quality system, along with detailed knowledge of gaining, maintaining and developing ISO 9001, ISO 13485 and ISO 22000 processes and procedures. 

우대사항

1.      Must have experience of working with an electronic quality management systems software to assist with the development of practical systems using certain quality management systems software.

2.      Have experience working as supplier auditor in Life Sciences, Medical Device and/or Pharmaceutical company for initial Supplier Quality Systems audit, which will cover all aspects of the operations associated with the manufacturing processes and practices for the following filters from material receipt to finished product release.

3.      Has experience of working with an electronic quality management systems software to assist with the development of practical systems using certain quality management systems software.

4.      Possess analytical and technical skills required to understand business practices and recommend proper opportunities.

5.      Excellent written, verbal, and interpersonal communication skills for effective interface with all internal and external contacts.

6.      Prefer to have practical hands-on experience of six-sigma (to at least Green Belt level) and Lean Manufacturing and all its supporting tools, e.g. 8D, statistical studies (SPC, capability, stability, R&R, etc), Validation and Failure Mode & Effects Analysis, along with the ability to train and educate personnel in these tools..