5 Cgmp Norms Jobs

As a Production Operator in the Plant, your role involves performing production activities in shifts. You will be responsible for operating process sequences through computer systems / HMI and communicating effectively with supporting departments such as QA, QC, warehouse, Engineering, and safety. Your coordination with DCS operators is crucial for the smooth functioning of operations. Key Responsibilities: - Perform activities as per Standard Operating Procedures (SOPs). - Fill Batch Production and Usage log book online. - Carry out all production activities in compliance with current Good Manufacturing Practices (cGMP) norms. - Prepare SOPs, Master Production Batch Records (MPBR) / Batch Production Batch Records (BPBR), Protocols, and conduct Operational Qualification (OQ) and Performance Qualification (PQ) activities of equipment as required. - Report near misses, incidents, and deviations to senior authorities. - Ensure adherence to safety and cGMP norms among colleagues. - Provide job training to contract workmen for shift operation activities. Qualifications Required: - Relevant experience in production activities within a manufacturing plant. - Knowledge of cGMP guidelines and SOP adherence. - Ability to operate computer systems and HMI effectively. - Strong communication skills for coordination with various departments. - Prior experience in reporting incidents and deviations. - Capability to provide training to contract workers. Please note that the above responsibilities and qualifications are essential for this role of Production Operator.,

Role Objective: A key objective of this position is to oversee and optimize the injection molding manufacturing process. This role involves ensuring compliance with SOPs, maintaining high standards of personal hygiene and cleanliness in the manufacturing department, and managing various aspects of the injection molding production, including productivity, rejection control, R&D and equipment maintenance. Desired Candidate Profile: Bachelors degree in engineering or a related field with a minimum of 10-12 years of experience in injection molding manufacturing. Knowledge of ISO 13485:2016 standards. Familiarity with cGMP norms. Working experience with the SAP module. Role & Responsibilities: Ensuring and monitoring the productivity of Injection molded parts as per capacity. Ensure adherence to SOPs and processes in the Injection Molding manufacturing process. Rejection Monitoring and control in Injection molded parts as per defined norms. Execution of R&D work related to Mold, Injection moulding plant department. Continuous Monitoring control in mold condition and repairing as per requirement. Coordinate with suppliers and vendors regarding trials, requirements, and corrections. Continuous Monitoring control in Machine and repairing as per requirement. Maintain and ensure the documentation in the injection molding department as per ISO 13485:2016. Process optimization and troubleshooting in Injection Molding process. To ensure production completion in Injection is moulding department as per production planning. Take trials of new molds and materials. To attach routing and quality plan for new injection-molded parts coded in the system (SAP). Installation of all new equipment, OQ, PQ and new process validation. Create SOPs. Ensure that periodically review of all SOPs of department. Support to QA/QC department for documentation, complain, Root cause, CAPA and technical related requirement To ensure preventive and periodic maintenance of the machine and mold on time. Work on the design and coordination of the new mold. Spend time in the molding plant and collect observations. Monitor the works of operators/employees of the Injection Molding division. Process training to operators. Maintain the cGMP norms in the injection molding plant. Functional/Technical Skills: Strong understanding of injection molding processes. Proficiency in using SAP and T-codes. Knowledge of ISO 13485:2016 standards. Problem-solving and troubleshooting skills. Leadership and managerial abilities. Excellent communication and interpersonal skills. Attention to detail and a commitment to quality. Ability to work in a fast-paced manufacturing environment. Behavioral Skills Required: Strong leadership and team management capabilities. Analytical mindset with effective decision-making abilities. Proactive and adaptable to dynamic manufacturing environments. High level of accountability and ownership. Effective collaboration with cross-functional teams. Team Size to be Handled: Lead and supervise a team of 3-4 team members, reporting to the General Manager Manufacturing. Important Links: Website: https://biotechhealthcare.com/ LinkedIn: https://www.linkedin.com/company/biotechhealthcare/ Instagram: Biotech Vision Care Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc. Show more Show less

You should possess a D.Pharma/B.Sc. qualification with 1-2 years of experience to be considered for this role. As the position holder, your core job responsibilities will include: - Ensuring compliance with cGMP norms in the warehouse and dispensing area. - Adhering to warehouse-specific SOPs in daily routine work. - Following EHS norms in the warehouse and dispensing area. - Practicing Good Documentation in the warehouse and dispensing area. - Completing raw material dispensing plans on time and without errors. - Updating the WMS system daily to track material movement. - Conducting physical stock verifications as per the specified SOP. - Providing timely training to NMS based on the scheduled training matrix. - Timely completion of warehouse-related projects.,

As a qualified candidate for the position, you should hold a diploma in Pharmacy or a Bachelor's degree in Science. With 1-2 years of experience, you will be responsible for ensuring compliance with cGMP norms in the warehouse and dispensing area. Your duties will include adhering to warehouse-specific SOPs, maintaining EHS norms, and practicing Good Documentation in both areas. Your primary responsibilities will also involve timely completion of raw material dispensing plans with accurate dispensing, updating the WMS system daily to track material movement, conducting physical stock verifications as per SOP, providing training to NMS according to the scheduled matrix, and ensuring timely completion of warehouse-related projects.,

You will be responsible for operating Water system RO1, RO2, RO3, RO5 plant at Dholka in accordance with the standard operating procedures (SOP). This includes carrying out preventive maintenance of Water system equipments and treating water as per the SOP. It is crucial to maintain updated records in compliance with cGMP norms to ensure smooth operations and prevent major breakdowns. Efficient operation and maintenance of the water system up to the user point is essential. This involves following the scheduled preventive maintenance for the year, promptly addressing breakdown maintenance, and ensuring that all Water System Equipments are always in good condition. You will also be required to perform modification and development work in machinery under the guidance of the engineer. Timely reporting of materials needed for maintenance and daily report writing are key aspects of the role. Additionally, you must maintain a clean working environment, ensure the safe and proper use of tools, and report any unusual observations to the site engineer. It is important not to leave duty until handing over charge to the reliever or informing the superior.,