60 Job openings found

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 ...

Good Knowledge of USFDA/ EDQM /ANVISA / and all other regulatory & CGMP awareness. Strategic oversight and leadership: Develop and implement the company's quality management system (QMS) and strategy, aligning it with business objectives. This includes overseeing all aspects of quality operations and managing the QA and QC departments. Regulatory compliance: Ensure ...

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

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: Analysis of raw material & finish product. Conduct shelf life analysis. Calibration of lab instrument. Knowledge of ISO 22000, FSSAI, HALAL, USFDA & Other legal requirement. Analysis swab testing and air monitoring. Co-ordination with plant for FSSAI, HALAL & ISO 22000 Maintain all documents as per legal & organization requirement.

Position :      Maintenance Engineer Location :      Vapi Experience:   3 - 5 Years Industries:    Chemical Responsibilities: Maintain API manufacturing equipment (reactors, centrifuges, dryers, pumps, mills) Perform preventive, breakdown, and shutdown maintenance Handle utilities: boiler, chiller, HVAC, compressed air, cooling tower Ensure GMP, EHS, and SOP compliance Maintain maintenance records, logs, and history cards Support audits (USFDA/WHO) and ...

Candidate must have experience from Pharmaceutical Industry and should be ready for traveling for site work across Gujarat and India also.   Execute CSV activities as per GAMP 5, 21 CFR Part 11, and EU Annex 11 Prepare and execute validation deliverables: Validation Plan / VMP sections URS, FS, DS Risk Assessments (FMEA / Risk-based) IQ, OQ, ...

The Quality Assurance professional is responsible for ensuring that pharmaceutical products are manufactured, tested, and released in compliance with GMP and regulatory requirements. The role focuses on documentation, compliance, audits, and continuous quality improvement. Roles and Responsibilities GMP & Compliance Ensure compliance with GMP, GDP, GLP, and regulatory guidelines Review and approve SOPs, BMRs, ...

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, ...

The job description is as below: The R&D Manager - NDDS will lead formulation and development of novel drug delivery systems, from concept to scale up and tech transfer, ensuring compliance with regulatory and quality standards and alignment with business goals. The role requires strong scientific depth in NDDS, team leadership ...