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.
- 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.
- Knowledge of analytical chemistry, chromatography (HPLC/GC) and drug dissolution testing.
- Familiar with LIMS, 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.
- Ensure real time documentation.
- Maintain data integrity and appropriate traceability.
COMPLIANCE AND QUALITY:
- Thorough knowledge and understanding of BP, USP, cGMP and FDA guidelines.
- Maintain a clean and safe work environment and follow safety procedures and policies.
- Create and maintain lab record documentation (notebooks and computer based) per GMPs
EDUCATION & EXPERIENCE:
- Degree / Diploma in Science related discipline.
- Minimum 5 years of experience in a pharmaceutical environment
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.
