13 Job openings found

The job description is as below: Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements. Key Responsibilities 1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...

Key Responsibilities: 1. Method Development & Validation Develop analytical methods for assay, dissolution, related substances, and stability testing. Conduct method validation as per ICH guidelines (accuracy, precision, specificity, linearity, robustness). Optimize and troubleshoot existing analytical methods. 2. Instrument Handling Operate analytical instruments such as HPLC, GC, UV, FTIR, KF, Dissolution Apparatus, etc. Perform daily calibration and ensure ...

Position:          QC Executive Location:          Silvassa  Experience:      6 - 10  Years Industries:       Pharma   Responsibilities: Analytical Testing: Perform routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples using HPLC, GC, UV, IR, etc. Conduct assay, dissolution, impurity profiling, and related substance testing as per pharmacopeial standards (USP, BP, IP, etc.). Instrument Operation & ...

Position:          Dy. Manager - Quality Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma API  Responsibilities: Quality Management System (QMS)   Establish, implement, and maintain an effective Quality Management System in line with cGMP, ICH, USFDA, EU-GMP, WHO, and other regulatory requirements. Ensure compliance with SOPs, policies, and ...

Key Responsibilities Method Validation & Development Perform method validation as per ICH Q2 (R1/R2) guidelines Develop, optimize, and validate analytical methods for assay, impurities, dissolution, and residual solvents Conduct method verification and method transfer activities Prepare and review validation protocols and reports Instrumentation & Analysis Operate and maintain HPLC, UPLC, GC, and related detectors (UV, PDA, FID, ...

Position:         QA Officer Location:        Ankleshwar Experience:    4 - 5 Years Industries:     Pharma   Responsibilities:         Ensure GMP compliant operations and robust Quality Management System (QMS) execution for API manufacturing at the Ankleshwar site, including documentation control, batch release support. Batch Documentation & Release: Review BMR/BPR, analytical reports, COAs; ensure compliance with specifications ...

Job Description: We are seeking a skilled and experienced microbiology professional to lead microbial testing and environmental monitoring activities in an API manufacturing setup. The Assistant Manager will ensure compliance with regulatory standards, supervise microbiological operations, and support quality systems in the microbiology lab. Key Responsibilities: Oversee routine microbiological testing of raw materials, ...

Job Description: We are hiring an experienced QC professional to lead and manage quality control operations in our API manufacturing unit. The Assistant Manager will be responsible for supervising analytical activities, ensuring regulatory compliance, handling audits, and supporting continuous improvement initiatives. Key Responsibilities: Supervise routine analysis of raw materials, intermediates, and finished APIs Review ...

Analysis of Inprocess, Intermediate, Raw Material, Stability and Finished product samples as per approved specification/Test method/Protocol and recording of analytical data in to analytical data sheet.   Prepare and standardize the volumetric solution and reagent as per SOP  by following the Good Laboratory practices, Good documentation practices during the analysis.   To prepare QC ...

Experience in pharmaceutical company handling of instrumentation and calibration processes and hands on experience in handling QMS documentations.Note : Only Formulation OSD background is eligible   Knowledge of various PLC, DCS, SCADA, HMI To plan for preventive maintenance as per schedule for all equipments in manufacturing area and maintain its records along with ...