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Qc Pharmacist
2 weeks ago
**Requirements:Qualifications**:
- Bachelor's Degree in Pharmacy
- Work experience, minimum 2 years, in pharmaceutical QC position is advantage
- Good knowledge of GMP or GXPs practices
- Experience in ISO/IEC 17025 is advantage
- Basic knowledge and experience with laboratory instrument performing analytical tests such as HPLC, GC, FTIR, Spectroscopy
- Good command of English Language
**Responsibilities:Role & Responsibilities**
- Take QC Role in a new project of facility/equipment/process and support team which is related to quality control function
- Prepare documentation of Quality Control as GMP required (e.g. Specification, Test Procedure, Stability Protocol, Standard Operating Procedure, Test Report, Certificate of Analysis)
- Responsible for quality control and approval of incoming raw material and packaging material for manufacturing process
- Perform physical/chemical/microbiological testing for intermediate/finished product as per material specifications
- Organize product stability testing and maintain stability report for quality review and regulatory audit
- Participate in Method Transfer of new product analytical procedure (as required) to ensure the reliability of testing result - transfer method from R&D Department
- Support a group of validation team in the area of laboratory testing for all validation activities
- Support Quality Management System to monitoring product quality and ensuring strictly compliance with GMP regulation and other relevant Quality Guidelines such as ICH.