8 Cgmp Documentation Jobs

Roles & Responsibilities: Operate and supervise packing operations and packing machinery efficiently. Ensure adherence to Good Manufacturing Practices (GMP) in all packing activities. Have knowledge of Packing Material (PM) dispensing activities and PM store management. Perform reconciliation of packing materials to ensure accuracy and avoid discrepancies. Maintain all packing-related documents as per cGMP requirements . Ensure compliance with company policies and quality standards during packing operations.

Supervise and manage production activities in API, bulk drugs, or pharmaceutical manufacturing. Ensure production processes comply with cGMP standards and FDA regulations. Maintain accurate production records and documentation as per cGMP guidelines. Monitor workflow, coordinate with team members, and ensure timely completion of production targets. Troubleshoot production issues and implement corrective actions to maintain product quality. Ensure adherence to safety, quality, and operational protocols on all shifts.

As an experienced candidate with 2 to 5 years of relevant experience, you should possess a strong knowledge of QMS / cGMP documentation related to engineering. Additionally, you should have knowledge of calibration of instruments related to temperature, pressure, level, flow, and weight. Understanding basic concepts of PLC and SCADA, including their operation, will be essential for this role. You are expected to have knowledge about breakdowns and be able to prepare breakdown analysis data. Familiarity with P&ID diagrams, hook up diagrams, and different types of on-off valves and control valves is required. Your responsibilities will also include handling projects, managing contractors for a...

You will be responsible for ensuring the quality control, warehouse operations, engineering, and production activities in the Fill and Finish department. **Quality Control:** - As an Operator, you should have ITI qualification with 1 to 5 years of experience in handling samples, chemicals, reagents, and SAP procurement. - As an Analyst- Chemical, you should hold a B.Pharm/B.Sc/M.Sc. degree with 2 to 8 years of experience in HPLC, GC, Dissolution apparatus, and UV Visible Spectrometer. Knowledge of weight analysis and stability studies for Injectable dosage forms is required. **Warehouse:** - The Shift In charge role requires Any Graduate/Postgraduate with 6 to 10 years of experience in wareh...

You are invited to join Zydus LifeSciences Ltd. at their Injectable manufacturing plant in Ahmedabad. We are currently looking to fill the following positions: 1. Production: - Staff positions ranging from Executive to Assistant Manager require candidates with a B. Pharm / M. Pharm/ B.E background and 4 to 10 years of experience in Supervising and Controlling Production areas such as Isolator, Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, and Visual Inspection. Knowledge of QMS activities is a plus. - Plant Operator and Technical Assistant roles require candidates with a Diploma or ITI qualification and 3 to 6 years of relevant experience in operating production machines like Isolat...

As the Production Head, you will be responsible for overseeing the manufacturing activities in the pharma API industry. With 15 to 19 years of experience, you will be based at the Sandhurst Road Mumbai head office with a salary of 15 lpa. Your key responsibilities will include reviewing, approving, and distributing work instructions for manufacturing activities. You will ensure the production activities align with the production plan and make decisions regarding new batch production. Monitoring batch processes and reviewing online documentation such as BMR, BPRs, logbooks, and daily records will also be part of your role. Furthermore, you will be in charge of qualifying production equipment,...

You should have a strong knowledge of QMS /cGMP Documentation related to engineering. Additionally, you must be familiar with calibration of instruments related to Temperature, pressure, Level, flow, and weight. Basic knowledge on PLC, SCADA, and its operation is required for this role. It is important to understand breakdown and prepare breakdown analysis data. You should also be knowledgeable about P&ID diagrams and hook up diagrams, as well as all types of on-off valves and control valves. Handling of projects, contractors for Addition and Alteration of Equipments/Building facilities, and high voltage substation, Generators & Instrument control system is part of the responsibilities. You ...

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operatio...