Quality Control Expert - API (2-4 yrs)
Job Description :
- In-process analysis of all the intermediates and finished products.
- Standardization of chemical lab instrument like KF titrator, calibration pH meter, Balance / HMA daily weight checks on daily basis.
- Intermediate and finished product analysis in HPLC.
- Updating the logbooks of all laboratory instruments present in the laboratory.
- Testing and releasing of all the in-process samples after receiving the in-process analysis request from production.
- Preparation of mobile phase for HPLC reaction monitoring analysis.
- Reaction monitoring analysis of intermediates and finished products.
- Analysis of cleaning validation sample.
- Sampling of all the intermediates and finished products (Exdrier) after receiving sample advice sheet from production.
- Testing and releasing of non SAS intermediate samples and pasting of approved labels for non SAS intermediates.
- Review of in-process documents.
- Hand over the in-process analysis documents to production.
- Monitoring and recording of refrigerator and laboratory temperatures.
- Glassware cleaning.
- Disposal of solid and liquid waste.
Salary:INR 2,50,000 - 3,50,000 P.A.
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Role Category:Production/Manufacturing/Maintenance
Role:Quality Assurance/Quality Control Executive
Employment Type: Permanent Job, Full Time
Keyskills
hplc kf titrator ph meter finished products cleaning validation QC Quality Control API active pharmaceuticals active pharma
Desired Candidate Profile
- Pharma background with regulated environment i.e. understanding of pharma GMPs
- Experience of handling Waters HPLC or Agilent GC Head space with Empower software
- Understanding of US 21 CFR part-11 compliance (i.e. computer records and electronic signatures)
- Experience of facing audits by regulatory agencies like US FDA, UK MHRA, EDQM etc.
Education-
UG: B.Sc - Any Specialization
PG:MS/M.Sc(Science) - Any Specialization
Doctorate:Doctorate Not Required
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.