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2.0 - 5.0 years
3 - 8 Lacs
Manesar
Work from Office
Role & responsibilities Understand the BOM and its level. Expertise in ECN/PCN Management and initiate & implement with impact analysis. Coordinate with Customer or Designer to understand the Product to prepare the Feasibility study and Risk analysis. List out the Tool & Fixture requirement and co-ordinate with team to get the Tool & Fixture on time. Validate the Product and calculate the Cycle time & Line Balancing. Setup the Product Line. Prepare the Stage Wise PFC, Work Instruction and PFMEA. Validate the Product tool & fixture and prepare the Validation Report. Identify the Critical to Quality and Critical to Process with Golden Samples. Capable to handle multiple product in parallel. Monitor the Issue tracker and find the root cause to take corrective action. Prepare the First Article Report and coordinate with Customer for approval. Expertise to handle the Customer. Expertise to provide the Product Training to Production Operator. Expertise in Process and Procedure Knowledge. Good Communication/Presenting Skills. Understand the DFA of Mechanical Assay.
Posted 2 months ago
2.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Role & responsibilities We are hiring experienced Groninger Machine Operators and Production Executives with a strong background in managing Vial Filling and PFS (Pre-Filled Syringes) Lines. The ideal candidates should have hands-on experience with Groninger machinery, ensuring smooth production operations while maintaining strict quality and safety standards. Key Responsibilities: Operate, monitor, and maintain Groninger machines used in Vial Filling and PFS Lines. Ensure seamless production flow, achieving targets without compromising on quality. Perform routine maintenance and troubleshooting of machines to prevent downtime. Monitor process parameters and ensure compliance with GMP (Good Manufacturing Practices). Conduct in-process checks and ensure adherence to standard operating procedures (SOPs). Collaborate with quality control and assurance teams to ensure product integrity. Maintain detailed records of production activities, machine performance, and quality checks. Implement safety protocols and contribute to a safe working environment. Preferred candidate profile Educational Qualification: Diploma / Engineering Degree in Mechanical / Pharmaceutical. Experience: Minimum 2-6 years of hands-on experience in operating Groninger machines, specifically in Vial Filling and PFS Lines. Strong knowledge of GMP, regulatory guidelines (USFDA, / MHRA / EU), and production documentation. Ability to work in a team-oriented environment with minimal supervision. Experience with other filling machines in sterile environments. Knowledge of automation and control systems. Familiarity with machine calibration and validation processes. Perks and benefits
Posted Date not available
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