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6.0 - 10.0 years
5 - 7 Lacs
vapi
Work from Office
Handle the Recovered Section. Assist in investigations related to out-of-specification (OOS), deviations, and laboratory incidents. Review and verify entries in logbooks, worksheets, and other controlled documents. Required Candidate profile Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory
Posted 3 weeks ago
2.0 - 7.0 years
3 - 7 Lacs
tirupati
Work from Office
Role & responsibilities Monitoring of preventive maintenance, Calibration, HVAC Validation and other Schedules Review of Temperature Mapping, Calibration Certificates Ability to handle Process, HVAC Validations and Equipment Qualifications Monitoring of Filter Cleaning and Differential Pressure of AHU's Review of Water and Environmental Trends Monthly and Yearly Handling of trackwise for QMS related activities Handling of Compliance wire for training related activities Preparation & Review of Annual Product Quality Review reports APQR Experience in handling audits Reviewing of Calibration schedule, Preventive maintenance schedules and Equipment qualification protocols and reports Reviewing o...
Posted 3 weeks ago
4.0 - 8.0 years
4 - 8 Lacs
vadodara, gujarat, india
On-site
Responsible for driving / initiating analysis of Critical test on HPLC and UV instruments Responsible to manage critical quality issues (Deviations, Incident, OOS Stability failures, etc.) and escalate any issues whenever required. Responsible for analysis of Critical test on HPLC and UV instruments. Responsible for calibration of various instruments as per schedule. (I.e. HPLC, Spectrophotometer, dissolution) and troubleshooting on instruments if required. Responsible to review Site Spec/STP/MOA before proceeding for analysis to ensure availability of resources to proceed analysis activity without any discrepancy. Responsible for Effective review of Analytical Raw data and Calibration repor...
Posted 1 month ago
2.0 - 5.0 years
3 - 5 Lacs
valsad, dadra & nagar haveli, daman & diu
Work from Office
Role & responsibilities 1. To review batch release documents for raw material/packing material /in process/intermediate /finished product/stability like test protocol / report, electronic data, chromatograms, audit trail, spectra, etc. 2. To execute audit trails and review the activity to verify the integrity of data. 3. To review electronic data back up and verification of restoration study, computer system validation, etc. 4. To review calibration/qualification/PM schedule/installation documents for instruments in Quality Control department. 5. To review analyst qualification and training related documents of quality control department. 6. To review documents related to working standard / ...
Posted 1 month ago
2.0 - 7.0 years
3 - 7 Lacs
Tirupati
Work from Office
Role & responsibilities Audit Trail Review Batch Release Method Validation & Transfer Review Calibration Records Review Analytical Raw Data Issuance OOS, Lab Deviation CAPA QC Review Experience in handling audits Preferred candidate profile Should have participated in Audits and exposure towards it Should be qualified in Chemistry knowledge in process and production Smart enough to understand the regulatory requirements Knowledge in regulatory and GMP. Perks and benefits As per Company norms
Posted 3 months ago
6 - 11 years
7 - 9 Lacs
Bharuch, Jhagadia, Ankleshwar
Work from Office
Creation and Maintain relevant master data in the LIMS, Ensure that the integrity, reliability and performance of the LIMS is maintained. Address and resolve issues arising with the system in a timely manner Required Candidate profile Ready to work in Morning or General Shift To manage the QMS processes—including OOS investigations, Deviations, Incidents & Change Control & to ensure strict adherence to GDP & GMP within lab
Posted 5 months ago
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