Primary Job Function

This position is responsible for Quality control, Test Method Transfer coordination and product release relevant general management activities complying with Korea GMP, applicable regulatory standards and corporate requirements. The employee covers document control, artwork development and revision, activities related product release, QC reagents and standard supply, complaint handling, training etc.

 

Major Responsibilities

1. Product batch release

• Inspect packaging materials and document on an inspection record
• Issue redressing instruction
• Review packaging records for products locally redressed and verify that the redressing was appropriately conducted
• Review incoming inspection records for finished goods including retrieving shipping temperature data
• First review of Batch records on QC testing, redressing, label inspection
• Issue Certificate of Product release
• Request QC testing to contracted labs
• Request and maintain retention samples

2. Change Control, Nonconformance(NC) and CAPA Management

• Issue or review records for change and NC locally initiated
• Conduct Impact assessment, investigation, set up action plans, effectiveness check as per related procedures

3. Complaint Management

• Intake complaints from internal / external customers and create complaint records in system
• Communication with stakeholders and coordination for product compensation
• Send back corresponding samples to manufacturing sites for investigation and close records based on global investigation
• Inform investigation results to customers if requested

4. Internal and external inspection

• Address inspector’s requests during audit
• Set up action plan for any observations identified by auditors after root cause investigation, and complete required actions and effectiveness check
• Maintain any other related documents

5. Supplier Management

• Coordinate/Conduct supplier evaluation and performance monitoring
• Make a service contract/Quality agreement with local Third Party Lab
• Maintain any other related documents

 

6. Artwork Management

• Develop Artwork for finished products licensed in Korea
• Issue Label Change Request via system and track artwork change
• Coordinate schedule of implementation with local SCM and global artwork coordinator

7. Test Method Transfer

• Participate selection process of proper local lab for TMT
• Coordinate TMT between transferring lab and receiving lab
• Review TMT protocol and report
• Cooperation with MSnT to issue TMT protocol and report

8. Annual Product Quality Report (PQR)

• Collect required data and information for PQR of each product, including PQR of manufacturer
• Create/Maintain PQRs

9. Training

• Provide training to employees about GMP, GDP, local procedures etc.
• Attend training for drug or food
• Archive training documents
• Manage train activities as a local training coordinator (back-up)

10. Reagent Supply

• Order reagents and standard materials required for local QC testing
• Communication with team to obtain required documents for import
• Manage importing process of the reagents etc. including government approval

11. Others

• Review records of facility control, shipping inspection, nonconforming products and returned products.
• Address/Support any regulatory submission to local health agency
• Support Validation including mapping study
• Manage financial activities for QA team such as initiation of Purchase order and requesting QC testing expense
• Back up QA Specialist during his(her) absence.

 

Education & Experiences Requirements

• Bachelor’s degree or equivalent in pharmacy, chemistry, biology or related scientific discipline
• Pharmaceutical qualifications in an experienced quality system management discipline or equivalent would be desirable.
• 2-3 years’ experience of working and managing a quality assurance in pharmaceutical company. (prefer)
• Familiarity with the Pharmaceutical Law and related regulations and GMP knowledge
• Proficiency in MS Office
• Basic English Communication Skills

   담당자: 김대식
   연락처: 02-6925-5391
   이메일: ds@hrfind.co.kr