1114 Change Control Jobs - Page 2

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Works independenly on creating test plans, executing tests, troubleshooting the issues, automating test cases, reporting bugs with all the required details, reviewing the tests, providing the test reports, analyzing test failures Capable of analyzing moderately complex challenges using analytical tools and data interpretation. Applies critical thinking to assess problems with relevant data independently to evaluate potential solutions after considering various possibilities. Engages in independent analysis and collaborates with others to gather insights and develop recommendations including challenging existing processes. Capable of working independently while actively contributing to team a...

To ensure the GMP and GLP compliances. To participate in OOS, OOT, Deviation and complaint investigation, root cause analysis and to review investigation report. To carry out closure activities. To compile data provided by manufacturing, warehouse, QC for preparation of complaint investigation report. To prepare and review trends of OOS, OOT, Deviation, complaints, customer audit/inspection. To initiate change controls pertaining to QA and to review change controls of other departments w.r.t impacted activities. To review change control trend. To compile data for and prepare, review risk assessment reports w.r.t. Deviation, OOS, OOT, Nitrosamine impurities, elemental impurities, etc. To appr...

Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Ster...

.Create and maintain company Q.A documentation, manuals, procedures .Continuously improve QA processes and procedures. .Preparation of QA reports. .Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 Required Candidate profile Thoroughly Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017

As a member of the Consulting organization, you are responsible for ensuring that a quality, integrated software solution is delivered in a timely manner, at budget, and to our client's satisfaction. This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery. Responsibilities Experienced in managing large-scale and complex Oracle Cloud implementation and transformation projects from initiation to completion. Create and lead comprehensive project plans covering budget, structure, scheduling, staffing models, and resourcing while ensuring alignment with Oracles compliance, security...

Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc.As a member of the software engineering division, you will assist in defining and developing software for tasks associated with the developing, debugging or designing of software applications or operating systems. Provide technical leadership to other software developers. Specify, design and implement modest changes to existing software architecture to meet changing needs.Duties and tasks are varied and complex needing independent judgment. Fully competent in own area of expertise. May have project lead role and or supervise lower level personnel. BS or MS degree or equivalent experienc...

Intermediate consulting position operating independently with some assistance and guidance to provide quality work products to a project team or customer that comply with Oracle methodologies and practices. Performs standard duties and tasks with some variation to implement Oracle products and technology to meet customer specifications. This position requires functional knowledge of Oracle Utilities products (CCB, MDM, C2M, CCS, etc.) and would involve System Testing and System Integration testing for Implementation and Upgrade projects. Responsibilities As a member of a project team, follows standard practices and procedures to analyze situations/data and provide quality work products to de...

Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. Responsibilities As a member of the software engineering division, you will take an active role in the definition and evolution of standard practices and procedures. Define specifications for significant new projects and specify, design and develop software according to those specifications. You will perform professional software development tasks associated with the developing, designing and debugging of software applications or operating systems.

Intermediate consulting position operating independently with some assistance and guidance to provide quality work products to a project team or customer that comply with Oracle methodologies and practices. Performs standard duties and tasks with some variation to implement Oracle products and technology to meet customer specifications. Responsibilities Standard assignments are accomplished without assistance by exercising independent judgment, within defined policies and processes, to deliver functional and technical solutions on moderately complex customer engagements.

Manage a team that designs, develops, troubleshoots and debugs software programs for databases, applications, tools, networks etc. Responsibilities As a manager of the software engineering division, you will apply your knowledge of software architecture to manage software development tasks associated with developing, debugging or designing software applications, operating systems and databases according to provided design specifications. Build enhancements within an existing software architecture and suggest improvements to the architecture. Qualifications Career Level - M3

Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. Responsibilities As a member of the software engineering division, you will apply basic to intermediate knowledge of software architecture to perform software development tasks associated with developing, debugging or designing software applications or operating systems according to provided design specifications. Build enhancements within an existing software architecture and occasionally suggest improvements to the architecture.

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

Role Overview: At bp, you will be part of the Global Concept Development (GCD) organization within P&O Projects, responsible for developing a global portfolio of upstream oil and gas projects, including decarbonizing opportunities on existing assets. As a Front-End Project Engineer based in Pune, India, your role will involve early business and facilities planning for major projects, focusing on Pre-Projects (FEL1) and Concept Development / Optimize / Pre-FEED (FEL2). You will play a key role in selecting safe, commercially robust project concepts and driving efficiency gains to shape the future of the business. Key Responsibilities: - Demonstrate a strong commitment to HSE (Health, Safety, ...

As a QMS Specialist at Pharmanovia, you will play a crucial role in supporting the effective operation, maintenance, and continuous improvement of the global Quality Management System (QMS). Your responsibilities will include ensuring quality compliance across all GxP activities, contributing to the design and implementation of quality systems, monitoring quality processes, and providing oversight across business functions. You will report directly to the Associate Director Internal Quality System and be expected to have a broad understanding and experience of QMS requirements, operation, and compliance in a GMP and GDP environment. Key Responsibilities: - Maintain and update controlled qual...

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master...

Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensu...

Job Title - Electronics Sourcing & NPD Engineer Experience - 1 to 3 years (Entry level) Location - Mumbai (Dadar) Work Mode - Work from Office Work Week - Monday to Friday Role Summary: We are looking for a proactive and technically sound Electronics Sourcing & NPD Engineer to manage electronic component sourcing, engage with global vendors and partners, and support end-to-end electronics development from concept to mass production. The ideal candidate will have hands-on experience with IC manufacturers, global distributors, PCBA suppliers, and EMS/ODM partners, along with strong working knowledge of fabrication processes and supplier evaluation. Key Responsibilities: Sourcing & Procurement:...

EXL Services.com ( I ) Pvt. Ltd. is looking for Executives to join our dynamic team and embark on a rewarding career journey Reviewing documents to determine type of request(s) and process them as per set guidelines Processing transactions received through faxes, web submissions, mail, Contact Center requests, etc. Processing a wide-range of non-financial transactions through good order review for incoming contract changes due to death claim or divorce transactions. Knowledge and proficiency of multiple mainframe systems necessary. Researching in automated work distributor for duplicate work items, routing as necessary. Redirect documents to appropriate operational area as needed Contribute ...

EXL Services.com ( I ) Pvt. Ltd. is looking for Executives to join our dynamic team and embark on a rewarding career journey Reviewing documents to determine type of request(s) and process them as per set guidelines Processing transactions received through faxes, web submissions, mail, Contact Center requests, etc. Processing a wide-range of non-financial transactions through good order review for incoming contract changes due to death claim or divorce transactions. Knowledge and proficiency of multiple mainframe systems necessary. Researching in automated work distributor for duplicate work items, routing as necessary. Redirect documents to appropriate operational area as needed Contribute ...

EXL Services.com ( I ) Pvt. Ltd. is looking for Executives to join our dynamic team and embark on a rewarding career journey Reviewing documents to determine type of request(s) and process them as per set guidelines Processing transactions received through faxes, web submissions, mail, Contact Center requests, etc. Processing a wide-range of non-financial transactions through good order review for incoming contract changes due to death claim or divorce transactions. Knowledge and proficiency of multiple mainframe systems necessary. Researching in automated work distributor for duplicate work items, routing as necessary. Redirect documents to appropriate operational area as needed Contribute ...

analyse, design, engineer, deploy and maintain global Cyber Security systems work closely with Project Managers, Technical Architects, 2nd level support, and IT Business Analysts provide technical consultancy to the project team maintain technical documentation relevant to operations (operational manual, installation guide, etc.) Job Requirement Excellent knowledge of Red Hat Linux environments in a large enterprise BASH scripting and Python programming skills (or equivalent programming experience) Skills to design, plan and deliver solutions in a large-scale enterprise environment Experience with change control using Git Fluency in English Technical communication and documentation skills Ex...

Preparation and review of Standard Operating Procedures To review the vendor qualification documents and ensure the compliance in line with the SOP. Follow up for the vendor Qualification activities. To review Technology transfer documents. To ensure that approved vendor list is updated as per the Vendor Qualification SOP Review and execution Equipment, Utility, and other Qualification activities. Issuance and review of Batch Production and Control Records, Batch Cleaning Records, formats, Registers, Standard Operating procedures, Analytical Records and other documents. Review of master and executed batch production control records, Batch cleaning record and analytical documents. Preparation...

Job Purpose At Intercontinental Exchange (ICE), we engineer technology, exchanges and clearing houses that connect companies around the world to global capital and derivative markets. With a leading-edge approach to developing technology platforms, we have built market infrastructure in all major trading centers, offering customers the ability to manage risk and make informed decisions globally. By leveraging our core strengths in technology, we continue to identify new ways to serve our customers and transform global markets. We're looking for motivated, results-oriented people to join our team. As a Senior Business Analyst, you will be drafting business and functional requirements for deve...