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 [email protected] 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.
