A foreign pharmaceutical company is seeking a ‘Head of Qualityr’ as follow;

* Job Title: Head of Quality

* Position: Isa ~ Bujang

* Reporting Line: Plant Director

* Location: Gyunggi-do

{Summary of Position}

1. Provide leadership and management to the Quality Assurance and Quality Control Team at plant so as to achieve GMP (Good Manufacturing Practice) compliance. 

2. Continuously evaluate plant quality assurance and quality control systems, and make quality and operational improvements as needed through management and change control systems, so as to comply with all requirements to satisfy the regulatory requirements in the markets, including MFDS and PIC/s standards, and as requested by company.

3. Prepare, review, and approve Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records, and other necessary GMP documents, for activities related to plant operations, and support Corporate SOPs and policies.

{Responsibilities}

1. Maintain GMP compliance

- Provide training to staff on site on GMP, and monitor people’s training plans for GMP compliance.

- Management of the investigation of complaints and recalls related to non-compliance with quality requirements of medicines produced at Company, and at a 3rd Party manufacturing facility.

- Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations.

2. Operation support 

- Provide quality support to manufacturing.

- To provide wide-ranging support to the Company Group Quality Team and other personnel in Quality and Operations as needed.

3. 3rd Party management 

- Review Technical Agreements with 3rd Parties as required, and work with Company Corporate Quality as needed.

- Approval and monitoring of the manufacturing and control conditions at contract manufacturers and testing facilities, through audits, or other means.

- Approval and monitoring of the suppliers of active ingredients, excipients, packaging, and other  materials, through audits, or other means.

4. Organisation & Team management

  - Management of staff, including objective setting for staff, and regular reviews of staff performance in line with Company and Company Group systems.

- Management of budgets for the quality organization. 

- Work closely with the Company Corporate Quality and Operations and Compliance Teams worldwide as required.

- Lead the Company organization through any required regulatory, customer, and external audits.

{Requirements}

- Pharmacist (Korea) 

- Bachelor degree in pharmacy (preferably a Master's degree) so that the person can be registered with MFDS. The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry

- Professional experience – preferably 10 years, but not less than 5 years, of uninterrupted work experience in the production and/or control of pharmaceuticals.

- To be well acquainted with the MFDS standards, and preferably also European standards on Good Manufacturing Practice (EU-GMP) and Good Laboratory Practice (GLP), as well as other international GMP standards.

- Good computer skills.

- Good command of Korean and English 

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently.  Only qualified candidates will be contacted for interview.  All resumes not contacted will be kept in DB confidentially for future positions.

Kyung Jin KIM

CEO & Executive Search Consultant

Exdigm Inc.

Email: ceo@exdigm.com