다음과 같이 외국계 제약회사에서 'Head of QC'를 찾습니다.

* Job Title: Head of QC

* Experience: Over 10 years ~

* Location: Gyunggi-do

[RESPONSIBILITIES]

1. Maintain GxP compliance

- Keep abreast of the requirements and the latest trends in GxP and attend suitable training to meet those needs.

- Provide training to QC employees on GxP and monitor of training plan, result and effectiveness.

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

2. Quality Control Management Roles

- Serve as QC Head on both sites QC teams.

- Direct the work activities of the raw material, finished product and stability studies to ensure that testing is executed in a timely and compliant manner

- Demonstrate technical proficiency in analytical methodology and adherence to GxP compliance

- Direct the work activities of all laboratory investigations

- Direct the work activities of all protocols and reports such as Analytical Method Validation, Analytical Method Transfer, Cleaning validation and Process Validation.

- Establish and implement a KPI structure to ensure optimal test/cost ratio

- Follow up on any Corrective actions from audits and ensure they are closed out.

- Assist with new product introduction by Analytical method transfer and support local registrations.

- Promote a positive approach to quality throughout the organization.

- Align organization's and QC staff's goals with company's goals and DNA, continue coaching to achieve the goal.

- Work closely with the Lotus Region Quality units as needed.

[QUALIFICATIONS]

- University degree or equivalent in Chemistry, Biology, Biotechnology or equivalent.

- Minimum of 10 years professional experience is required (in pharmaceutical industry/QC) in a GMP regulated environment for the production of pharmaceuticals or biopharmaceuticals. 

- A good background in analytical methods (HPLC, GC, UV, IR). Expertise in MV, PV, CV and Stability study. An excellent knowledge of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method and validations.

- Good computer skills.

- Good command of Korean and English 

- Fully engrained quality person

- cGMP Laboratory management expert

- Deep and professional understanding of Data Integrity (ALCOA) Management 

- Deep and professional understanding of Quality Management System of Pharmaceutical Industry

- Good Knowledge of cGMP

- Diverse experience of GMP audits (as Auditee and Auditor)

- Passion for continual improvement and challenges

- Strong mindset for accountability, proactive thinking and commitment

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