35 Job openings found

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

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 ...

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 ...

Key Responsibilities: Handle QMS activities including CAPA, Change Control, Deviation, and OOS/OOT. Prepare, review, and maintain QMS documentation as per cGMP and regulatory guidelines. Support internal audits, external audits, and regulatory inspections. Ensure timely closure of quality incidents and continuous improvement initiatives. Coordinate with cross-functional teams for compliance and quality culture. Requirements: B.Pharm / M.Sc (Chemistry) with ...

Key Responsibilities: Analytical Operations: Perform routine and non-routine analysis using HPLC, GC, UV and other instruments. Conduct and support analytical method validations as per regulatory requirements. Review and approve analytical data, test reports, and batch release documents. Ensure proper calibration and qualification of laboratory instruments. QMS & Compliance: Manage Quality Management System (QMS) activities including:OOS, Deviations, CAPA, ...

Key Responsibilities: 1. Compliance & Risk Management: Ensure compliance with all applicable EHS regulations (e.g., OSHA, ISO 14001, ISO 45001, local environmental laws). Conduct risk assessments, HAZOP studies, and job safety analyses (JSA). Maintain regulatory records and ensure timely reporting to authorities (e.g., pollution control board, FDA). 2. EHS Program Development & Execution: Develop and implement ...

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, ...

Key Responsibilities: 1. Recruitment & Staffing Handle recruitment for manufacturing, QA, QC, production, engineering, warehouse, and admin departments. Screen resumes, schedule interviews, conduct HR rounds, and manage offer letters. Coordinate with department heads for manpower planning. 2. Onboarding & Induction Complete joining formalities, new employee documentation, ID cards, and induction program. Ensure training on GMP, safety, and ...

Oversee day-to-day production activities for formulation batches as per approved BMR/BPR. Ensure compliance with cGMP, GDP, and regulatory guidelines (WHO, EU, USFDA, MHRA as applicable). Monitor production planning, batch scheduling, material requirement, and manpower allocation. Coordinate with QA, QC, Warehouse, Engineering, and RA for smooth production operations. Review and ensure timely completion of batch ...

Able to prepare PVP, URS, SIA, FMEA, JHA, FRS, DS, IQ, OQ, PQ protocols Lead validation activities for projects, ensuring compliance with regulatory requirements and industry standards. Execute validation protocols and procedures. Conduct risk assessments and develop mitigation strategies. Collaborate with cross-functional teams to ensure project objectives are met. Review and approve validation documentation. Provide technical ...