19 Gmp Guidelines Jobs

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As a Blister Filling Machine Operator in the Injectables Division of the Production Packaging department at our company, you will play a crucial role in ensuring the efficient operation of blister packing machines. Your responsibilities will include: - Operating and monitoring blister packing machines following SOPs and GMP guidelines. - Performing machine setup, changeovers, and basic troubleshooting. - Ensuring proper feeding, sealing, and packing of ampoules/vials in blister packs. - Monitoring printing, batch coding, labeling, and packaging integrity. - Maintaining machine hygiene and conducting cleaning validation. - Conducting in-process checks to ensure sealing, batch coding, and pack...

As a C&Q Engineer at Jacobs, you will be responsible for project delivery, design management & project management, for positioning and winning projects involving a range of services. You will collaborate with commercial, project management, engineering, and design technical leaders to create opportunities for Jacobs to plan, develop, deliver, and operate a range of projects. **Role And Responsibilities:** - Knowledge of Risk-based Integrated C&Q approach - Provide input into all aspects of C&Q from design through to commissioning and qualification completion - Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements - Prepare C&Q protocols a...

As a Trainee/Chemist at Synnat Pharma Private Limited, a leading API manufacturer, you will play a crucial role in ensuring that raw materials, in-process materials, and finished products meet stringent quality standards. Your responsibilities will include: - Raw Material Sampling and Analysis: - Perform sampling of raw materials following defined procedures, ensuring representative collection. - Conduct visual inspections to detect contamination or degradation. - Prepare samples using wet chemistry and instrumental techniques. - Accurately record sampling activities in laboratory notebooks/e-systems. - Compare results to pre-defined specifications and escalate deviations. - Maintain hygiene...

Job Description: As a Technical Operator in the Nutraceuticals department, you will be responsible for operating and maintaining pharmaceutical machinery such as Sachet, Rotary, Tablet Compression, and Alu Alu Blister. Your role will involve ensuring smooth machine operation, conducting routine maintenance, troubleshooting issues, and adhering to quality standards. Key Responsibilities: - Operate and monitor Sachet, Rotary, Tablet Compression, and Alu Alu Blister machinery. - Set up machines before production and conduct regular maintenance checks. - Monitor production output to maintain quality and compliance with GMP guidelines. - Perform troubleshooting and minor repairs to minimize downt...

As a Purchase Executive at Synnat Pharma Pvt Ltd, your role will involve streamlining API procurement processes to ensure cost-effective sourcing and robust vendor relationships. You will be responsible for identifying business needs, securing reliable suppliers, and negotiating optimal contract terms. Your key responsibilities will include: - Identifying and evaluating potential API suppliers based on quality, cost, and reliability aligned with the company's strategic goals. - Developing and maintaining strong relationships with key vendors to ensure consistent communication and collaboration. - Negotiating favorable contract terms and pricing agreements to achieve cost savings and optimal ...

As a Store Executive at our company, you will be responsible for managing day-to-day warehouse activities in compliance with Good Manufacturing Practices (GMP) guidelines. Your role will involve ensuring proper handling, storage, and issuance of materials, as well as maintaining accurate documentation and SOP adherence. You should have experience in the Pharma industry and be familiar with ERP systems. Key Responsibilities: - Ensure compliance with GMP and related documentation. - Prepare Goods Receipt Note (GRN) and oversee material receipt, handling, storage, and issuance. - Dispense materials according to SOP and batch requirements. - Operate and calibrate warehouse equipment as per sched...

* Activity & Resource Planning * Lead/represent Project Meeting with client. * Routine Correspondence with clients and all project stakeholders effectively & impressively * Conduct inspection of existing facilities and prepare GAP analysis report. Required Candidate profile * Conduct FAT * Knowledge and understanding of all relevant local statutory compliance requirements as applicable for the department * Understanding of Layouts and can develop the same .

Job Purpose Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost effective technical solutions. Ensuring technical quality to enable the overall site / project objectives .Maintenance Technician Responsible for execution of maintenance & calibration activities and commissioning activit...

This is a full-time on-site role for a Quality Control Officer. As a Quality Control Officer, you will be responsible for ensuring the quality and safety of products through laboratory testing and data analysis. Your primary duties will include conducting analytical tests using instruments such as HPLC, GC, UV, IR, Water content by KF, Auto titrator, and Dissolution Apparatus. Additionally, you will be responsible for quality assurance activities and effectively communicating results with team members and clients. To excel in this role, you should possess strong analytical and laboratory skills, along with hands-on experience in operating various testing instruments. Your ability to follow S...

As a Production Chemist at our WHO-GMP Pharma Factory, you will play a crucial role in overseeing the production processes of tablet medicines to ensure quality and efficiency in manufacturing. Your responsibilities will include managing manufacturing operations, maintaining quality control standards, optimizing processes, documenting production activities, ensuring equipment maintenance, adhering to safety protocols, and collaborating with the quality assurance and production teams for seamless operations. To qualify for this role, you should hold a Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related field, along with a minimum of 2 years of experience in a production chem...

As a Supply Chain Specialist for the Active Product Ingredient (API), Excipients, consumables, and component sourcing in the fast-growing clinical division, your main role involves identifying and agreeing upon the supply chain. You will be responsible for sourcing new products and suppliers, ensuring compliance with regulatory requirements and staying informed about market trends. Negotiating competitive prices is essential to support the business in achieving its targets and margins efficiently. Your responsibilities also include processing orders from other departments, managing the supply chain effectively, and maintaining a supplier base aligned with the company's commercial objectives....

Key Responsibilities : Technical Skills Candidate should have good understanding of Chemistry and biology pharma R&D lab. Candidate should have exposure of lab computing support in handling lab instruments needs. Candidate should have implementation experience of Electronic Lab notebooks (ELN) preferably Biovia or Perkin Elmer Candidate should be familiar with GMP guidelines. Experience in demonstrating a track record of delivering scientific solutions in the pharmaceutical and CRO industry. Experience in the implementation of Informatic applications like (Electronic Laboratory Notebooks(elNB), Laboratory Information Management System, Chromatography Data system (CDS) and other scientific ap...

As a Quality Assurance Officer at our organization, your primary responsibility will be to review and ensure compliance of Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and protocols across all our sites. You will also be required to conduct internal audits and provide support during external regulatory audits from bodies such as USFDA, WHO, MHRA, and others. Monitoring Corrective and Preventive Actions (CAPA) implementation and change controls will be part of your duties to ensure data integrity and Good Manufacturing Practice (GMP) compliance across our manufacturing units. You will also be responsible for evaluating product quality trends and preparing quality ...

As a Sr. Executive / Asst Manager (Shift Incharge) in the Production Fermentation (Upstream) department at Natural Biogenex Pvt. Ltd., you will play a crucial role in overseeing and leading shift-wise operations effectively. With 6 to 10 years of experience and a background in M.Sc. / B.Tech. / B.Sc. in Biotechnology, Microbiology, or Industrial Microbiology, you will be responsible for ensuring the smooth functioning of fermentation processes in compliance with SOPs and production schedules. Your key responsibilities will include supervising and monitoring shift activities, ensuring operational efficiency, timely escalation of issues, maintaining documentation as per GMP standards, managing...

You are urgently required to join Lavanya Healthcare Limited as a Sachet Packing Machine Operator. Your responsibilities will include operating, cleaning, and performing minor maintenance on sachet packaging machines. It is essential that you have 1 to 2 years of experience in sachet packing or similar machine operation and possess a 10th or 12th pass education qualification. Your role will be in the Production / Packaging department, and you should be well-versed with GMP guidelines. The work schedule is Monday to Saturday from 9:00 AM to 6:00 PM. The job type is full-time, and the work location is in person at Near Phillanto Company, Behra Road, Dera Bassi, Punjab. In addition to a competi...

The Form-Fill-Seal (FFS) Operator position entails operating and maintaining Form-Fill-Seal machines utilized in the production of IV Fluids. Your primary responsibility will be to ensure the smooth and efficient operation of these machines, along with monitoring the production process to uphold high standards of quality and safety. You will be tasked with operating and monitoring the Form-Fill-Seal machines, making necessary adjustments, and conducting routine maintenance procedures as required. It is crucial to ensure the proper functioning of the machines, troubleshoot and address any issues that may arise during production, and maintain compliance with standard operating procedures (SOPs...

Trending Job Description Key responsibilities. Responsible for working with Technology Transfer, Production, and the Client to generate, revise, and approve master production records (MPRs) and any other documents associated with the commercial products in the manufacturing, e.g., SOPs, material specifications, technical reports, etc. Preparing unplanned and planned deviations for responsible processes and forming the investigation team. Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure. Work with project and engineering teams to replace...

As a Project Manager in the pharmaceutical industry with a PhD (Doctor of Philosophy), your role involves overseeing and managing projects related to drug development, clinical trials, regulatory compliance, or other pharmaceutical initiatives Your advanced academic background in pharmaceutical sciences provides you with a deep understanding of the industry and scientific principles You develop project plans, timelines, and budgets, considering the specific objectives, deliverables, and resource requirements of pharmaceutical projects You coordinate with cross-functional teams and stakeholders to ensure effective project execution Risk Assessment and Management: You identify potential risks ...