11 Process Validations Jobs

Role Overview: You will be joining Edusoft Healthcare Pvt. Ltd. as a Manager in AERB-QC & Regulatory based in New Delhi. Your primary responsibility will be to oversee the quality control and regulatory compliance processes, including type approvals, AERB process validations, training the team, and leading the team in meeting AERB (Atomic Energy Regulatory Board) requirements on a daily basis. Key Responsibilities: - Obtain RSO (Radiation Safety Officer) certification from BARC - Demonstrate knowledge of AERB regulations and quality control standards - Manage new product type approvals and renewals - Execute regulatory compliance and quality control processes - Provide AERB process training ...

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. - Collaborate with key personnel like heads of production, quality control, quality assurance, and supply chain to supervise the company's activities and ensure continuous compliance with legal requirements. - Be regularly present at the facilities where the operations take place to over...

As a Manufacturing Process Engineer for car perfume products, your role involves developing and optimizing manufacturing processes and workflows to ensure efficiency, quality, and cost-effectiveness. You will be responsible for planning and executing tooling trials, pilot runs, and process validations to ensure reliability and consistency in commercial manufacturing. Additionally, you will prepare detailed technical documentation, including process specifications, SOPs, work instructions, and control plans. Key Responsibilities: - Prototyping and Testing Validation - Quality and Compliance: Identifying and addressing production issues, conducting root cause analysis, and implementing correct...

Location: India Contract: 12 months with possible extension Are you looking for a unique opportunity to drive quality excellence in pharmaceutical manufacturing Kelly FSP is seeking an experienced Senior Supplier Quality Assurance professional to actively support supplier selection, qualification, product transfers, process validations, and provide comprehensive quality oversight for API manufacturers. This position is part of an important API Restructuring Project. Key Responsibilities: Support the selection and qualification of suppliers through due diligence and audits. Provide quality oversight for product transfers and process validations, including equipment qualification. Ensure all p...

Job Description Responsibility TPM Exposure and awareness - PM, JH and KK pillars Handling Green/Brown Field Project - Plant Machinery Installation and Commissioning Process Validations - DQ,IQ,OQ and PR, RQ Sound Technical knowledge on Process equipment, Primary and Secondary Machines, Manufacturing Equipment Maintenance & Trouble shooting, spare parts management Monitor & Control Key KPIs - MTBF, MTTR, Maintenance Cost Develop team 100% compliance to EHS and Quality norms Regulatory Audits Implement & Enforce Safe Working Practices throughout the plant by adhering to all the Safety Standards developed by (MSI) My safety Index. ( Equipment Safety) Qualification & Co-ordination with internal...

Role Overview: You will be responsible for performing the microbial analysis of various water samples, raw materials, packaging materials, and finished products. This includes carrying out analysis of microbiology stability samples and market complaint samples. Additionally, you will participate in Analytical method transfers, equipment cleaning validation, and process validations to ensure quality control. Key Responsibilities: - Following QC SOPs and procedures in strict adherence to cGMP - Adhering to systems and procedures (SOPs) for conducting QC functions as per requirements - Ensuring that all equipment and instruments are in a validated and calibrated state - Maintaining media/cultur...

Role Overview: As a Manager in AERB-QC & Regulatory at Edusoft Healthcare Pvt. Ltd., your primary responsibility will be to oversee the quality control and regulatory compliance processes, including type approvals, AERB process validations, training the team, and leading the team related to AERB requirements on a day-to-day basis. This is a full-time on-site role based in New Delhi. Key Responsibilities: - Ensure compliance with AERB regulations and quality control standards - Manage new product type approvals and renewals - Implement regulatory compliance and quality control processes - Provide AERB process training to the team - Demonstrate strong analytical and problem-solving skills - Ut...

As a Qualified Person within the Quality department at Piramal Critical Care (PCC) in Haarlem, Netherlands, your primary responsibility will be to certify batches of Medicinal Products before release for sale. This includes ensuring compliance with EU-GMP regulations, relevant EU-directives such as 2001/83/EC and 2011/62/EU, Dutch National Legislations, and overseeing that public service obligations are met. - Collaborate with key personnel like heads of production, quality control, quality assurance, and supply chain to supervise the company's activities and ensure continuous compliance with legal requirements. - Be regularly present at the facilities where the operations take place to fulf...

Job Description: As a Specialist in Process Development at Dr. Reddys Laboratories Ltd., you will play a vital role in the pharmaceutical development process. Your responsibilities will include conducting strategy evaluations, designing and optimizing pharmaceutical processes, calculating batch sizes, performing scale-up calculations, handling exhibit batches, and preparing technical documentation. Your expertise will ensure the successful development and scale-up of pharmaceutical products, with a focus on oral solid formulations and process validations. Key Responsibilities: - Conduct strategy evaluations to design and optimize pharmaceutical processes for efficient and cost-effective deve...

As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP record...

Urgent Required Dy Manager - Process Design & Development in MNC for Lonikand Pune location, its near to Kaharadi, Pune Required Qualification: Bachelor's Degree Required Experience: 9 Yrs. to 12 Yrs. Role & responsibilities : Lead a team of Process design & development of wire harness products. Prepare development plan, develop, track the development progress and report to management. Study drawings, specifications & identify the product requirements related to manufacturing and testing of product, customer specific requirements. Prepare & maintain documentation related to mfg processes like PFD, PFMEA, list of equipments, tooling fixtures, list of SC,CC characteristics, floor plant layout....