Alembic Pharmaceuticals is looking for competent personnel to be an integral part of our Quality team for our new Formulation plant based at Karakhadi / Panelav in Vadodara, Gujarat.
Alembic Pharmaceuticals Ltd,
Opp. Bhailal Amin General Hospital,
Date & Day: 8th December 2018, Saturday
Time: 9:00 AM to 12:00 Noon
Qualification: B.Pharm / M.Sc / M.Pharm
Executive: Quality Control (IP/FP & Stability)
– Analysis of in-process, finished & stability samples of formulation-oral solids/injectable products.
– Preparation of stability protocols & handling of stability chambers.
– Exposure on analysis of process validation, hold time study and cleaning verification samples analysis
– Handling of QC instruments like HPLC, UV, KF, etc.
– Analysis of Reconstitution/Diluent Compatibility/In-use/Water loss studies
Executive: Quality Assurance (Analytical QA & Validation)
– Review of method validation/verification/transfer protocol and reports.
– Review of Specification, Analysis Report, Standard test procedure, Record of Analysis, General Test Procedure and Logbooks.
– Review of Water Reports, Raw Material, Packaging Material, In-Process, Finished Product and Stability analytical data.
– Review of analytical data in SAP.
– Review of analytical data in LIMS.
– Verification of electronic data generated at laboratory during testing.
– Laboratory instrument audit trail review.
– Handling of laboratory investigation.
– Review of SOP and Instruments Operating and calibration.
– Review and Verification of qualification/validation package for equipment / instrument.
– Verification of computer system validation data.
– Review of Calibration data.
– Review and impact evaluation of deviation and change control.
– Environmental Monitoring of Microbiology Laboratory and Manufacturing area.
– To carryout water sampling activities
– Preparation of trends for Environmental Monitoring and Water Quality Monitoring.
– To participate in Media Fill Activity.
– To participate in HVAC qualification of Microbiology Laboratory as well as manufacturing area.
– Qualification of Microbiology laboratory equipments as per the approved protocols as per requirement.
Preparation of Environment Monitoring and Water sampling related SOPs, Protocols and IOCPs.
To follow the Good Laboratory and Good Documentation Practices.
Coordinating with the Environment Monitoring team members and cross functional teams for better productivity.
– To prepare the trends as per the applicable frequency for Environmental Monitoring.
– Responsible for disposal and decontamination of used/expired media & Microbial Culture as per the defined procedures.
– Interested professionals matching the requirement may join us for Personal Interviews on 8th December ’18 @ 9:00 AM.