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Senior Specialist – Quality Control
1 month 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.
TO APPLY:
Candidates are encouraged to apply this position via email to Phghr@pharmagend.com with the following information in the resume.
· Work experiences and job responsibilities.
· Current and Expected salary
· Reason for leaving.
· Date of availability
· Education background
We regret that only shortlisted candidates will be contacted.
Tell employers what skills you have
FTIR
Pharmaceutical Industry
Quality Control
HPLC
Dissolution
GMP
Investigation
Traceability
Raw Materials
Chemistry
LIMS
Packaging
Laboratory
Manufacturing
Chemical Engineering
Calibration