Quality Control Analyst cGMP for pharmaceutical company for South Korea

Job Title Quality Control Analyst
Product Solid Dosage Forms Products
Job Level Analyst
Department Quality Control
POSITION SUMMARY
Quality Control Chemistry is responsible for performing analytical method validation/verifications for API, intermediate and final solid dosage form product, and testing intermediate and final product samples to demonstrate that all products meet all standards required for cGMP operations. Various techniques are utilized in Quality Control including HPLC, GC and multiple types of spectrophotometry. Additional functions include stability testing, assay transfers and the qualification of new instrumentation utilized in the Quality Control laboratory.
2. KEY ROLES AND RESPONSIBILITIES
This position is responsible for performing analytical methods verification/validation, and routine testing of API, in-process samples, stability samples and final products in accordance with SOPs for product release.
Core Responsibilities
Prepare and execute the analytical method verification/validation protocols and reports.
Perform Dissolution testing, HPLC and UV-spectrometry assays for in-process and final product samples.
Perform residual solvents and related substance assay for APIs.
Review of QC Data for compliance to procedures and specifications.
Calculate and evaluate results.
Successful completion of assigned training.
3. WORK EXPERIENCE
More than 8 years working experience with cGMP Quality Control Chemistry in global pharmaceutical companies
4. SKILLS AND CORE COMPETENCIES
Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:
Perform analytical methods verification and/or validation
Follow accurate written procedures for testing of in-process and final product samples.
Provide input to the technical composition of operating documentation.
Work in compliance with CGMPs.
Ability to handle multiple tasks concurrently, and in a timely fashion.
Must have basic understanding of laboratory instrumentation.
Must be able to communicate effectively with supervisors and peers.
Must be able to read, write and converse in English.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Knowledge of cGMP manufacturing and Quality Assurance preferred.
Knowledge of basic chemical and biological safety procedures.
Must display eagerness to learn and continuously improve.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
5. EDUCATION
Bachelor’s or Master’s Degree in Chemistry or Life Sciences discipline