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Specialist – Quality Control
2 weeks ago
KEY DUTIES AND RESPONSIBILITES:
- Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
- Preparation of reagents/diluents/ dissolution media as per STP.
- Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
- Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
- Ensure implementation of SOP for all corresponding activities.
- Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
- Ensure real time documentation, maintain data integrity and appropriate traceability.
- Assist in maintenance and calibration of test instruments per specifications.
- Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
- Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
- Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
- Responsible for QC lab and equipment/instrument cleanliness.
- Responsible for procuring and receipt of QC lab glassware and consumables.
- Any other activities as and when assigned by the Superior.
EDUCATION:
- Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering).
EXPERIENCE:
- (Specialist) Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.
- (Analyst) Fresh grad/ 1-2 years of quality control experience in pharmaceutical manufacturing industry.
KNOWLEDGE & SKILLS:
- Possess working knowledge of GMP in the pharmaceutical industry.
- A good team player with positive learning attitude.
- Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
