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Scope/Supervision and Interaction: Reports to the Division Quality Manager. Interfaces with domestic
and AP customers, Suppliers, SCM, Engineering, Laboratory, Marketing, Sales,
Manufacturing department engineers and other quality engineers. As an quality
system engineer, responsible for quality system management, participates in the
audit processes, both internal and external customer, certification and
regulatory bodies) through quality assurance and auditing techniques. Supports
the development and implementation of suitable quality philosophies for the
operating division based on best practise and customer and market needs. Essential Functions:
- Improve
processes base on ISO 9001, ISO 22000, ISO 13485, FDA, Pharmaceutical and
Biotechnology standards, practices and previous knowledge and experience.
- Develop, implement and report
the internal quality system audit and mock audit program with Division
personnel against ISO 9001 and Halal.
- Participates the audit
processes, both internal and external (customer, certification and
regulatory bodies) to identify opportunities for continual improvement.
- 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.
- 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.
- Carry out or complete any
activities required to support the needs or requests from customers and
regulatory authorities. For example, audits, questionnaires, agreements,
etc.
- Quality & Customer
Interface: Maintains system a corrective/preventive actions to analyze and
correct nonconforming conditions and complaints.
- To review a plan of change
controls and verify its changes with the necessary objective evidence.
- 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.
- Provide necessary support to
make sure the effective running of manufacturing site/Laboratory
calibration, maintenance and training systems.
- Provide quality management
software systems, regular cGMP training and related quality training to
all relevant employees across the site as needed.
- Provide support and guidance as
needed for the cleaning, calibration and pest control contractors.
- ISO 22000 / HACCP Certification
Promotion Leader and Support / deputize other certification such as Halal.
Job Requirements :
- Qualifications:
4 year college degree in Industrial engineering, Chemical engineering,
Biology or related department required with
certification in quality management preferred.
- 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.
- 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.
- 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.
- 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.
- Possess analytical and technical
skills required to understand business practices and recommend proper
opportunities.
- Excellent written, verbal, and
interpersonal communication skills for effective interface with all
internal and external contacts.
- 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..
Fluent written and verbal in English skills preferred.
Title : 부장 (7-11년) 영어 speaking skill 중상급, 제약/bio 관련 산업 경력자, 관련 업체 audit 유경험자 우대
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