[한국 화이자 제약] [PGS] Quality Operations Analyst(1yr contact) 채용

[PGS] Quality Operations Analyst(1yr contact)

 

 

Role Description

[KEY ACCOUNTABILITIES AND RESPONSIBILITIES]

- Validation and analytical instrument calibration
- Analytical Method Transfer Exercise
- Reports Laboratory Investigation Report (LIR) & Out of Specification (OOS) and support initial investigation
- Health and safety (EHS) handling
- Stability test
- Documentation including initiating SOP and import procedures
- Preparation of Registration documents
- Artwork
- Supports Quality Assurance Self Appraisal (QASA)
- Handles retain samples
- Handles Central Nervous System products
- Pharmaceutical Equivalence test
- Controls Quality Control Reference Standard and reagents
- Supports product complaints
- Implements basic and non-complicated activities and exercise judgment under significant supervision in a structured environment
- Makes decisions from limited options to resolve basic problems with limited effect on projects

 

[SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE]

- Education: BS degree in Science fields or pharmacy or above
- Or received equivalent education or have work experiences in the lab. of this field is preferred
- Able to communicate in English (written and spoken)
- Has fundamental knowledge of the principles of Quality Operations and basic GMP concepts and applies these skills to achieve assigned tasks

Job ID: 1048962

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