QA: GMP Group Manager

Experience:
・Approximately 3 years experience of quality assurance/control area or similar business area.
Knowledge:
・In-depth experience of GQP and GMP.
・Knowledge of pharmaceuticals and manufacturing processes (supplied by employer).
・An acquaintance with “Corporate Procedures” & Guidelines related to GQP and GMP.

Activities/Responsibilities:
・Prepare and maintain GQP documents
required by rPAL (SOP, GQP agreement,
product master file etc.).
・Enforce self inspection to confirm department
own GQP level.
・Enforce quality audits and develop quality
management for manufacturers.
・Coordinate/Assist change management
system (Local change review committee).
・Conduct assessments and adequately deal with
complain management system.
・Conduct investigation for quality improvement
and take necessary measures to suppliers.
・Follow up CAPA.
・Roll out developed/revised OCPs into the
quality assurance system.
・Collect information through medical industrial
network and reflect it into the quality assurance
system.
・Participate GMP audit as an observer and
assure the regulatory compliance for the foreign
manufactures within global organization.
・Participate and contribute to QA-QET meeting.
・Provide training opportunities for professional
skills.
・Support members to archive for their own
growth and professional goals.
・Maintain surroundings for competing with each
other.
・Evaluate subordinates accurately and
objectively.

Selling Points

・Manage the entire GMP team.
・Contribute to establish quality assurance system in compliance with rPAL & corporate standards and improve it continuously.
・Contribute to business activities of Manufacturing Division in the field of quality and technical areas.
・Participate GMP audit as an observer and
assure the regulatory compliance for the foreign
manufactures within global organization.
・Participate and contribute to QA-QET meeting.

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