48 Job openings found

Automation & Control System Management- Lead the operation, maintenance, configuration, and troubleshooting of Programmable Logic Controllers (PLC), Supervisory Control and Data Acquisition (SCADA) systems, and Distributed Control Systems (DCS). Ensure high availability and reliability of all critical automation and control systems across the facility. Manage system backups, security, and lifecycle management for all ...

Key Responsibilities:•Handling of QMS tools like change control, CAPA, Deviation etc.•Handle QA efficiently and able to maintain documentation as per GMP.•Preparation and maintenance of training schedule and co-ordinate with working staff to establish Procedures, Standards and System.•Preparation of Raw Material and Finished Product specification in accordance with Regulatory Guideline.•Vendor Evaluation, ...

  Execute preventive and breakdown maintenance of all equipment's (Plant & Utility) as per respective equipment checklist and SOP. Predictive Maintenance to Reduce Down Time Ensuring that all activities are performed in accordance with cGMP, cGLP, Company SOP and health & safety policies at site. Validation and Qualification of Equipment and Facilities. Management of the ...

Roles & Responsibilities: Operate and maintain utility equipment like chillers, air compressors, and nitrogen plants. Perform routine checks, preventive maintenance, and troubleshooting of utility systems. Ensure uninterrupted supply of utilities (air, water, nitrogen, cooling, etc.) to production areas. Maintain daily utility logs, pressure/temperature records, and compliance checklists. Follow cGMP, safety standards, and SOPs during utility ...

  We are looking for a Project Engineer with hands-on experience in installation, commissioning, and qualification of API equipment. The ideal candidate should have strong technical skills and prior exposure to API projects. Roles & Responsibilities: Handle installation and commissioning of API equipment. Ensure equipment qualification as per regulatory standards. Coordinate with vendors and contractors ...

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 ...

Job Description: Production Operator We are looking for skilled and reliable Production Operators with hands-on experience in API manufacturing. The ideal candidate will be responsible for executing day-to-day production activities, ensuring efficient batch processing, and maintaining GMP and safety standards. Key Responsibilities: Perform routine production operations such as batch charging, centrifugation, material handling, ...

Responsibilities: Operate and monitor capsule filling machines as per SOPs. Perform line clearance, changeover, and basic machine maintenance. Ensure accurate capsule weight, sealing, and batch output. Maintain GMP compliance, documentation, and safety standards. Coordinate with QA/QC for in-process checks. Requirements: ITI/Diploma/Graduate with 2–5 years’ experience in pharma capsule filling. Knowledge of cGMP, SOPs, and machine troubleshooting. Attention to detail ...

Responsibilities Perform and supervise In-Process Quality Assurance (IPQA) OR QA checks during API manufacturing operations. Conduct on-line review of Batch Production Records (BPR) and ensure adherence to approved procedures. Ensure sampling, line clearance, and process compliance as per GMP/cGMP norms. Identify, record, and support resolution of deviations, non-conformances, and quality incidents during manufacturing. Support quality investigations and prepare required ...

  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 ...