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4.0 - 5.0 years
4 - 5 Lacs
vapi
Work from Office
Manages cGMP training, audits, and self-inspections. Reviews deviations, risk assessments, QA documents, and validation protocols. Prepares APQRs, updates quality manuals, ensuring compliance with QAMS, VMP, and quality systems. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 4 to 5 LPA 4-5 Years
Posted 23 hours ago
7.0 - 11.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for preparing and reviewing validation documents such as Area Qualification for new facilities, Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Control System Qualification, commissioning, validation & re-qualification, and Revision Qualification for equipment/utilities/facilities. You will generate reports that summarize results, specifications, and acceptance criteria. Your role will also involve authoring documents in ValGenesis. In addition, you will track SOPs due for review, circulate them for comments, update comments, initiate change control, initiate ERA workflow, and follow up for execution, approval, and closure. You will prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements. Reviewing Calibration reports and updating them on a daily basis will also be part of your responsibilities. Furthermore, you will be required to prepare, track Purchase orders, update data sheets, arrange quotes for new equipment as needed, and update the required status and database for engineering activities in an Excel sheet. Initiating QAMS documents in Caliber will also be one of your tasks. Qualifications: - B.E./B. Tech Experience: - 7 to 8 Years,
Posted 4 days ago
2.0 - 5.0 years
2 - 4 Lacs
Tarapur
Work from Office
Role & responsibilities Quality Control: Min 2-5 years relevant experience in Quality Control Lab. Hands on experience in handling various instruments like (HPLC is must),GC,KF. Knowledge of GLP, GDP and lab safety. Awareness of Quality-QAMS, LIMS software. Qualification: M.SC / B.SC (Chemistry) with min. 02 to 05 Years Quality Assurance: Min 2-5 years relevant experience in Quality Assurance. Sampling activity, IPQA, QAMS, Documentation, Review of BPR. Awareness of Quality-QAMS software etc. Qualification: M.SC / B.SC / B. Pharma with min. 02 to 05 Years Note: Highest degree must have 1st Class/60 % marks and if 2nd class then 05 years of experience is must
Posted 2 months ago
2.0 - 5.0 years
2 - 4 Lacs
Tarapur
Work from Office
Role & responsibilities Quality Control: Min 2-5 years relevant experience in Quality Control Lab. Hands on experience in handling various instruments like (HPLC is must), GC,KF. Knowledge of GLP, GDP and lab safety. Awareness of Quality-QAMS, LIMS software. Quality Assurance: Min 2-5 years relevant experience in Quality Assurance. Sampling activity, IPQA, QAMS, Documentation, Review of BPR. Awareness of Quality-QAMS software etc. Note: Highest degree must have 1st Class/60 % marks and if 2nd class then 05 years of experience is must.
Posted 2 months ago
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