92 Change Controls Jobs

As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will include: - Being a good mentor and motivator to the team. - Developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluating patents and developing non-infringement strategies, including the capability of developing Paragraph IV products. - Scaling up and opti...

Role Overview: As a Regulatory Affairs Manager, you will be responsible for monitoring the company's production activities to ensure compliance with applicable regulations and standard operating procedures. Your key responsibilities will include devising regulation compliance strategies, creating training programs for staff, conducting internal inspections, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in line with regulatory guidelines, evaluate changes in CMC documentati...

As a Manager at Sun Pharma Laboratories Ltd in Guwahati - Operations OSD, your role will involve the following responsibilities: Role Overview: You will be responsible for monitoring and maintaining documentation related to QMS activities, including SOPs, change controls, deviations, and CAPAs. Additionally, you will handle market complaints by conducting root cause analysis and implementing corrective actions. Your role will also require ensuring implementation and compliance with Quality Management System (QMS) guidelines and facilitating training programs for personnel on QMS procedures, regulatory requirements, and best practices. Compliance with Good Manufacturing Practices (GMP) and co...

Job Responsibilities To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to e...

Role Overview: As a Senior Executive at Syngene International Ltd. in Bangalore, you will be responsible for performing validation of computerized systems for biopharmaceutical manufacturing facilities, as well as commissioning & qualification and validation activities for these facilities. Your role will involve coordinating the Calibration Program, Preventive Maintenance Program, and Alarm Management for the biopharmaceutical manufacturing facilities. You will also be responsible for participating in capital projects, conducting facility walkthroughs and audits, and implementing risk management strategies. Additionally, you will support the preparation and implementation of Standard Operat...

Role Overview: As an Analyst - Quality Assurance (Analytical Quality Assurance) at Immuneel, you will be responsible for in-process and batch QC activities. You will collaborate with internal QA, manufacturing, quality control, facilities operations, environmental health safety, and regulatory departments to ensure Analytical QA requirements are met and compliant with cGMP standards. Key Responsibilities: - Conduct Analytical Quality Assurance and development quality assurance tasks. - Review specifications, STP & ATR of raw material, packaging/consumable material, in-process, DS, DP finished product, and stability samples. - Review Certificates of Analysis (CoA) for various materials and pr...

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...

Role Overview: As a Regulatory Affairs Manager, your main responsibility will involve monitoring the company's production activities to ensure compliance with relevant regulations and standard operating procedures. You will be tasked with devising strategies for regulation compliance, organizing training programs to educate staff on policies and standards, conducting internal inspections and awareness campaigns, and staying updated on the latest rules and regulations in the industry. Key Responsibilities: - Demonstrate expertise in CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in adherence to ...

As a Specialist Product Analyst - Industrial DataOps/Data Engineer at our company, you will play a crucial role in enhancing our data aggregation, management, and contextualization capabilities by leveraging cutting-edge Industry 4.0 technologies and industrial DataOps tools. Your passion for innovation and contribution to the evolution of operational technology in the manufacturing sector will be highly valued. **Key Responsibilities:** - **Technical Leadership:** - Assist in designing and implementing technical solutions using Industry 4.0 technologies to enhance shop floor data aggregation and management. - Collaborate with senior architects and product leads to establish technical standa...

As the Quality Management Systems Specialist, your role will involve initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. Additionally, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your responsibilities. Key Responsibilities: - Initiate, review, and approve quality management systems including Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints - Handle Return Goods and perform risk assessments to ensure the proper functioning of the qualit...

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for s...

You will be a part of the Technology Transfer Team under the R&D vertical at Palli location. Your primary responsibilities will include: - Preparing Master BMR, BPRs, and managing documents - Coordinating with various departments such as Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, and Engineering for the execution of Scale-up and Exhibit batches - Reviewing GMP related documents and selecting equipment at the facility Your role will involve: - Facilitating Change Controls for various reasons and initiating them due to revisions in BMR/BPRs and other PD related changes - Studying critical parameters during scale-up batches to optimize the CPPs and CQAs - ...

As a QA Docscell at our company, your role involves ensuring compliance with cGMP, ICH guidelines, and regulatory requirements. You will be responsible for reviewing and maintaining batch manufacturing records (BMRs), batch packaging records (BPRs), and quality documentation. Additionally, you will conduct in-process checks and line clearance during manufacturing and packaging activities. Your responsibilities will also include participating in internal audits, self-inspections, and external regulatory audits. You will review and assist in the preparation of SOPs, protocols, and reports. In case of deviations, CAPA, change controls, and OOS/OOT results, you will investigate and document them...

Job Description The role will have the following responsibilities: Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format. Co-ordinate and follow up stability studies at contract research organizations (CROs)/ Chemical Quality Control lab of Orion (CQC). Co-ordinate and follow up validation and method transfer at CROs. Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. Reviewing and comment...

Job Description : Work Schedule Standard (Mon-Fri) Environmental Conditions Office Purpose: Provide basic business/system support for software systems and laboratory instrumentation. Collaborate with various departments and clients to initiate and complete performance qualification (PQ) validation activities. Facilitate the validation process, system upgrades, and ongoing support of software systems. Essential Functions: Participate in project teams, contribute to system enhancements, review change requests, and ensure effective communication and testing accuracy. Provide validation support for new releases and modifications throughout the software development life cycle. Prepare validation ...

Role Overview: You will be overseeing manufacturing and production operations at Dr. Reddys Laboratories Ltd., ensuring compliance with regulatory audits and managing equipment, process validation, and various activities related to production and manufacturing. Key Responsibilities: - Handle line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing. - Manage equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc. - Perform process validation for Sterilization, Washing, Aseptic filling, and cleanin...

As an Engineering Compliance Specialist, your primary role will be to ensure all engineering activities are carried out in compliance with cGMP, GEP, and site SOPs. This includes handling quality documents such as Change Controls, Deviations, CAPA, and Quality Risk Management. You will review and update the planner to ensure activities are completed on time and prepare/revise SOPs for plant machinery, utilities, HVAC, and water systems. Additionally, you will support preventive maintenance execution, assist in equipment installation/commissioning, and ensure effective training through review and feedback. Your responsibilities as a Department Training Coordinator will involve updating traini...

As a Supervisor at Sigachi, your role is crucial in ensuring the smooth functioning of production activities while maintaining high quality standards. Sigachi, a renowned manufacturer of Excipients for Pharma, Nutra, and food industries, values employee creativity, expertise, and wellbeing to achieve excellence. **Key Responsibilities:** - Plan and organize production schedules to achieve production targets, quality, and yield. - Ensure all production operations adhere to GMP standards and SOPs. - Supervise employees, casual workers, and contract workers to ensure compliance with SOPs. - Collaborate with the Quality Control department for continuous improvement and effective utilization of r...

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborati...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are looking for a motivated individual to support cGMP compliance within procurement operations. In this role, you will assist with key compliance activities such as investigating deviations, supporting CAPAs, coordinating supplier audits, handling change controls, and...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for ensuring Stability related activites Job Responsibilities Revie...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for ensuring Stability related activites Job Responsibilities Revi...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The purpose of the Associate/Senior Associate/Principal Associate MQO is to support the development and implementation of the strategy for quality sys...

As a dedicated and detail-oriented Quality Management System (QMS) Executive, your role will involve supporting and enhancing the organization's quality framework. You will be responsible for implementing, maintaining, and continuously improving the QMS in accordance with ISO 9001:2015 and relevant regulatory standards. Your main focus will be ensuring quality compliance across departments and fostering a culture of continuous improvement. Key Responsibilities: - Implement and maintain the Quality Management System in alignment with ISO 9001:2015 standards. - Develop, review, and control quality documents such as SOPs, manuals, work instructions, and records. - Plan and conduct internal audi...

Job Responsibilities To ensure the daily operations of analytical lab in ARD Department. Responsibility to analytical method development, validation, and routine testing. Manage release and stability testing of raw materials, in-process, and finished products on time. Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines. Ensure the lab instrument calibrations and maintenance as per the in-house protocol. Responsible for implementation of GLP activities in ARD lab. Responsibility to verify the all log books on daily basics. Preparation standard operating procedures in ARD Lab. Responsibility to ensure the sample management system in ARD Lab. Responsibility to e...