50 Job openings found

Job Description: We are seeking a dedicated QMS professional to oversee and maintain the Quality Management System in compliance with cGMP and regulatory requirements. The role involves managing documentation, handling quality events, and supporting internal and external audits in an API manufacturing environment. Key Responsibilities: Implement and maintain QMS processes in line with ...

COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines   COA/ Certificate of Analysis MSDS Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries Must have knowledge of Pharmacopoeias, ICH guidelines,

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 ...

Position:         Asst. Manager/ Manager - ADL Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma - API  Responsibilities: Analytical Development & Validation   Lead development, optimization, and validation of analytical methods for APIs, intermediates, and finished dosage forms. Perform method validation as per ICH, USP, EP, and IP ...

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 ...

Job Responsibilities: Maintain QMS documentation, SOPs, training records & audit readiness Conduct internal audits for clinical, BE & pharmacovigilance operations Support vendor audits, gap assessments, CAPA tracking, compliance reviews Ensure adherence to ICH GCP, regulatory guidelines & quality standards Required Qualification: B.Pharm/M.Pharm/MSc in Life Sciences 1–3 years experience in QA within CRO/BE/Clinical Trial setup Understanding of QMS, risk ...

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:         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 ...

Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's. Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & ...