1740 Change Control Jobs - Page 15

Design QE methodology and test approaches that validate features developed by Agile / Scrum teams and ensures the accuracy of the requirements Drive, scope, design and code automated tests Create automation best practices Participate in our Agile process by being an active contributor in daily standups, sprint kick-offs, demonstrations, and retrospectives Make recommendations for improvements in how we engineer our products. Perform manual and automated QE processes for new releases, and for routine maintenance. Report defects and testing status Design test environment in QE Lab Simulate real-world deployments of the products, and reproduce customer issues Required education Bachelor's Degre...

Role : Executive Small Volume Parenteral Manufacturing Location: Ahmedabad Department: Injectable / Sterile Production Key Responsibilities: Production Operations: Plan, organize, and execute the manufacturing batches of small volume injectable products. Operate / supervise key equipment: vial/ampoule washing, sterilization (autoclave, filtration), filling, sealing, capping, tunnel sterilizer, lyophilizer (if applicable) etc. Ensure line readiness, material dispensing, line clearance before/after operations. Aseptic Process & Sterility Assurance: Maintain cleanroom operations, gowning, environmental monitoring, microbial monitoring. Ensure correct operation of aseptic filling / sterile filtr...

Job Title: DGM - R&D Quality. GCP QA Business Unit: Global Quality & Compliance Job Grade G8 Location : Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Implement GCP requirements as per...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Responsibilities: Documentation & Record Review: Review specifications, sampling instructions, test methods, and analytical reports. Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records. Review completed Batch Production Records and Laboratory Control Records post-batch completion. Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports. Review and finalize Certificate of Analysis (CoA) for finished products. Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports. Review Standard Operating Procedures (SOPs) and Annual Product Quali...

Job Responsibilities: Responsible to monitor operations in granulation, blending area, compression, coating and tablet inspection area. Responsible to manufacture and ensure quality of the product at respective processing area. Responsible for online documentation with real time data. Responsible to ensure high degree of discipline in daily workings. Responsible to ensure all operation of production adherence to cGMP compliance Responsible on manpower development (training) for quality, productivity and cost consciousness To train the production personnel on cGMP Trend & regulatory requirement. Monitor the work of subordinates and ensure that the necessary assistance is provided to them for ...

Documentation- BMR review, Day to day documentation, Qualification, Validation, Deviation ,Change control, OSS, Incident, Market complainant, CAPA.

Responsibilities: Maintain database on regular basis. Verify data and correct database. Review and verify the entries. Respond to queries for information and access relevant files Comply with data integrity and security policies Required Skills: Logical thinking. Organizing. Good Computer knowledge Good communication.

Responsibilities: To impart the departmental training & co-ordinate for cGMP training as per planned schedule. To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings. To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report. To review the deviation, change control, incident for impact on product quality and safety in QAMS. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment. Review of QA documents, review of spe...

We are looking for a Data Analyst to join our Employer Data Team in Bangalore . This is an amazing opportunity to work on U.S. Market Access landscape and evolving payer/employer models . The team consists of three colleagues and is reporting to th e Manager . We have a great skill set in data analysis , primary and secondary research , SQL , advanced Excel, and we would love to speak with you if you have skills in the US healthcare space and a penchant for working with data. About You experience, education, skills, and accomplishments Experience in US healthcaremarket with familiarity with healthcare datasets, U.S. payers, PBMs or employer benefits Exposure to SQL Proven experience in prima...

About The Role Project Role : Engineering Services Practitioner Project Role Description : Assist with end-to-end engineering services to develop technical engineering solutions to solve problems and achieve business objectives. Solve engineering problems and achieve business objectives using scientific, socio-economic, technical knowledge and practical experience. Work across structural and stress design, qualification, configuration and technical management. Must have skills : Aircraft Structural Analysis Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Mechanical Engineering Practitioner, you will ...

About The Role Project Role : Engineering Services Practitioner Project Role Description : Assist with end-to-end engineering services to develop technical engineering solutions to solve problems and achieve business objectives. Solve engineering problems and achieve business objectives using scientific, socio-economic, technical knowledge and practical experience. Work across structural and stress design, qualification, configuration and technical management. Must have skills : Aircraft Structural Analysis Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Mechanical Engineering Practitioner, you will ...

Managing and leading team and Implement and enhance Quality Management Systems, managing all QA dep activities. Monitor laboratory activities to ensure strict adherence to GLP/cGMP procedures, promoting a culture of quality.

Job Title: Senior Officer – Process Engineering Business Unit: Engineering Job Grade G12B Location : Gangtok At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Execution of Breakdown maintenance...

We are seeking a highly skilled Senior Developer with practical experience in BPMN and DMN modeling, Blue Prism, Camunda Modeler, script tasks, REST APIs, inline scripting etc. Candidates should have completed at least 1-2 end-to-end Camunda projects. Prior experience with migration projects will be considered an added advantage Roles and Responsibilities Develop capability to quickly learn. Supports the analysis and build of processes from a technical perspective Performs development activity in accordance with the methodologies and standards set by the CoE Seeks guidance from the Process Optimization designer when facing complex tasks Provides status to Delivery Leads on the progress of de...

As an AEM Developer at one of the leading MNCs managing a critical project in the banking domain, your role involves utilizing your passion for technology and expertise in developing cutting-edge technology applications. **Key Responsibilities:** - Develop and manage cutting-edge technology applications in AEM 6.2 and above. - Utilize strong working knowledge of Java/J2EE, Servlets, Restful Web Services, XML, AJAX, JavaScript, and UI skills. - Implement development experience using Apache Sling, Apache Felix, Sightly, and OSGi Bundles. - Handle Workflow, Components Development, Environment Setup, and Dispatcher Configuration in AEM projects. - Utilize knowledge of Oracle Database SQL for eff...

Purpose And Scope Responsible for development, implementation, and change control of new and revised local labeling for assigned Astellas products and areas. Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. Research government initiatives related to labeling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners. Responsibilities And Acc...

About This Role At BlackRock, our smartest investment is you. We are a global investment manager helping more and more people experience financial well-being. BlackRock's business is investing on behalf of our clients, from large institutions to parents, grandparents, doctors, and teachers who entrust their savings to us. We are committed to our clients period. Our promise is to offer them the clearest thinking about what to do with their money and the products and services they need to secure a better financial future. Being a part of BlackRock means being a part of a community of thoughtful, ambitious people solving some of the most sophisticated financial challenges. Even with the company...

Date: 15 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Sterile Manufacturing, Filling Supervisor Department: Formulation production Job Location: Bengaluru, India About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. M...

About Flynaut LLC Flynaut is a global leader in digital transformation, partnering with startups, SMEs, and large enterprises across various industries since 2004. Our team of passionate professionals transforms visionary ideas into groundbreaking realities by delivering cutting-edge mobile apps, robust web platforms, and comprehensive IT solutions. With expertise in healthcare, finance, education, retail, and more, we craft tailored solutions that exceed expectations. We prioritize innovation and quality, building lasting relationships based on trust and transparency, and have successfully delivered hundreds of projects that drive tangible business outcomes. Role Description This is a full-...

Job Title Deputy General Manager (API) Business Unit Global API Business Job Grade G8 Location : Panoli At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities Responsibility of entire production department opera...

As a Global Regulatory, RWE & Medical (2RM) Quality Operations Manager at Opella, your role involves supporting the Global Regulatory, RWE, and Medical teams by implementing and maintaining Quality Systems to ensure that activities are conducted and data are generated, documented, and reported in compliance with GxP requirements. Key Responsibilities: - Event & CAPA: - Perform QA assessment, root cause analysis, and investigation report - Review and approve closure of CAPA - Ensure timely closure of investigations and CAPAs - Escalate risks to 2RM Lead and manager as required - Change control: - Create Change Control as per 2RM Quality Lead assessment - Coordinate until Change Control closur...

As a Financial Oversight Specialist, your key purpose is to provide proactive financial oversight and support across the project lifecycle. You will ensure robust project hygiene, accurate reporting, and strong stakeholder engagement. Your role involves serving as a key point of contact for project managers, delivering training, troubleshooting, and guidance to enhance financial awareness and project compliance. By conducting regular project reviews and providing insightful reporting, you will identify projects needing attention and collaborate with cross-functional teams to drive corrective actions. Ultimately, your position will contribute to the delivery of financially sound, well-governe...

Responsibilities: * Conduct BPR reviews * Ensure compliance with GMP & Change Control procedures * Monitor product quality through IPQA processes * Collaborate on BMR development and maintenance * Implement BPRs as needed Food allowance Annual bonus Provident fund

Job Title: Executive – R&D Biotechnology Business Unit: R&D1 Regulatory Affairs Job Grade G12A Location Baroda At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” JOB DESCRIPTION The candidate is expected to develop HP...