9 Cgmp Regulations Jobs

Job Description As part of the Global Quality team the Senior Specialist QA will be responsible for Managing systems to ensure quality, regulatory and GMP compliance expectations by Ensuring that all tasks are performed in accordance with quality policies and procedures, satisfy the requirements of cGMP and are in accordance with the appropriate regulatory guidelines. Interfacing with Manufacturing IT and other internal & external entities to align with quality policies and objectives Providing the independent quality approval of key qualification /validation documentations such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system rela...

Job Description Position: QA Sterile Manager Department: Quality Assurance Designation: Manager - I Education Qualification: M.Sc. in Biotechnology / Microbiology / Chemistry Total years of Experience: 10+ Years Job Role: Management of Quality Assurance functions of Manufacturing Block P. Responsibilities Ensure that manufacturing and packing of the batch is executed and records are completed and reviewed in accordance with established SOPs and cGMP regulations. Conduct certification of batch production records for compliance and stage-wise completion. To release / reject the Batch after complete review of batch and related quality documentation. Tracking and monitoring of QMS system. Ensure...

As a Manager - Production Derma (Ointment, Cream, Lotion, Gel), your role will involve overseeing various activities related to production operations in a Pharmaceutical Manufacturing facility. Your responsibilities will include: - Overseeing all activities from Raw Material dispensing to the final packing of products. - Approving and ensuring strict implementation of production operation instructions including SOPs and batch manufacturing processes. - Ensuring production operations comply with cGMP regulations and conducting initial and ongoing training for department personnel. - Managing documentation such as monthly stock statements and production reports. - Scheduling and overseeing cal...

As the Chemical and Instrumental Testing Analyst at Sun Pharmaceutical Industries Ltd, your role involves conducting testing on samples of raw materials to ensure the quality of products manufactured for both domestic and emerging markets. Your responsibilities include: - Conducting Chemical and Instrumental testing on samples of raw materials - Implementing system upgrades in alignment with CQ and regulatory guidelines - Analyzing and reporting stability and finished goods samples when necessary - Monitoring gowning and sanitation practices within the operational area - Ensuring compliance with standard operating procedures for analytical instrument operation - Operating analytical equipmen...

You will be joining Sun Pharmaceutical Industries Ltd as a QA Sterile Manager in the Quality Assurance department. Your role will involve managing the Quality Assurance functions of the Manufacturing Block P. As the Manager-I, you are required to hold an M.Sc. degree in Biotechnology, Microbiology, or Chemistry with over 10 years of experience in the field. Your responsibilities will include ensuring that manufacturing and packing processes are carried out per SOPs and cGMP regulations. You will be responsible for certifying batch production records, releasing/rejecting batches after thorough reviews, and tracking the QMS system. It will be your duty to investigate complaints, deviations, OO...

As the QC Systems Templating Senior Manager at Amgen, you will play a crucial role in leading the team responsible for creating and managing master data templates for Quality Control systems, such as ELN and the consumable inventory system, utilized globally across the Amgen QC network. Your strategic planning and prioritization skills will be essential in supporting the collective requirements of the QC organization while considering the individual needs and timelines of various sites. In this position, you will primarily work during regular hours to facilitate Amgen's mission of serving patients, and you will lead a shift-based team that provides coverage across multiple time zones. Flexib...

Key Responsibilities Strategic Operational Excellence: Develop and implement a comprehensive operational excellence strategy for the API manufacturing division, aligning with overall company goals and market demands. Process Optimization & Improvement: Lead initiatives to identify and eliminate bottlenecks, reduce cycle times, and optimize production processes across R&D, manufacturing, and quality control, with a focus on cost improvement. Cost Management & Profitability: Drive cost reduction programs and initiatives to improve absorption rates and maintain profitability in a competitive pricing environment. Quality Assurance & Enhancement: Collaborate closely with Quality and R&D teams to ...

As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely c...

As a Director Quality Assurance, Product Complaint and Surveillance you will report to the Executive Director, Quality Head and: Drive execution of the global complaints business process and continuous improvement Maintain oversight of complaints throughout the lifecycle from intake, processing, and through closure Apply in-depth knowledge and subject matter expertise to determine the steps necessary to improve the complaint management system to address the root causes for the complaints Provide accurate and robust surveillance information that meets global health authorities and Amgen requirements Manage the Business Performance team for Combination Product Quality at AIN to ensure timely c...