1120 Change Control Jobs - Page 35

Job Title: IT Regulatory Reporting Governance Coordinator Corporate Title: AVP Role Description The IT Regulatory Reporting Governance team provides an essential 24x7 service to manage IT regulatory reportable events related to IT incidents. The team is responsible for coordinating with IT stakeholders to assess, classify and ensure timely and accurate reporting to regulators. The team operates with a high level of expertise and coordination to manage the complex regulatory landscape effectively. A significant portion of the team's work involves ensuring compliance with the European Supervisory Authority (ESA) Digital Operational Readiness Act (DORA), which sets a new standard for regulatory...

Role & responsibilities 1. Monitoring and Managing the Quality Management System (QMS) Oversee the effective implementation and maintenance of the QMS across all departments. Ensure compliance with regulatory standards such as GMP, GLP, and ISO guidelines. Regularly review and update QMS documentation to reflect current practices and regulatory changes. Facilitate continuous improvement initiatives within the quality system. 2. Participation in Compliance, Investigations, and CAPA Effectiveness Lead investigations into quality deviations, non-conformances, and product complaints. Implement Corrective and Preventive Actions (CAPA) to address root causes. Verify the effectiveness of CAPAs to p...

JOB RESPONSBILITIES ON QUALIFICATION OF EQUIPMENT, FACILITY & UTILITIES - QA RESPONSIBILITIES: Ensuring of preventive maintenance of all equipments carried out as per schedule. Review of calibration certificates. Review of all equipment and utilities qualification documents (URS,IQ,OQ and PQ). Review of requalification protocol and reports for all equipments as per schedule. Review of temperature mapping protocol and report as per the schedule. Preparation of product quality review as per SOP. Review of preventive maintenance and calibration schedules and checklist. Issuance, retrieval and archival of registers to respective departments. Line clearance for equipments, clean room area and rep...

Title : REF72864X - Sharepoint Admin (3 to 5 years) - Mumbai - Assistant Manager TS Manage the overall health, performance, and availability of the SharePoint environment, ensuring optimal uptime and user experience. Configure and maintain SharePoint sites, lists, libraries, and other components to support business processes and collaboration needs. Customize and configure SharePoint sites, workflows, forms, and applications based on business requirements, using out-of-the-box features and SharePoint Designer.. Implement and manage user access controls, permissions, and security settings to ensure data integrity and compliance with Corporate Travel Managements policies. Monitor and audit Sha...

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 2...

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

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, analying 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 an...

As a QA (Quality Assurance) /Test Developer you will be designing better ways to identify potential weak spots, inefficiencies, and issues within software systems. This position will work closely with development teams and other test engineers in the implementation and delivery of software products that meet rigorous quality standards, budgets, and timelines. You will play a key role by delivering quality functions for development teams within test driven framework. Your scope will include Test Plan Development, Test Case Execution, Automation Testing, Data Creation, API Validation and incorporating test automation in the CI/CD pipelines. Your primary responsibilities include: Selenium Test ...

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Roles and Responsibilities Conduct quality reviews of documents, including CAPAs, change controls, and 21 CFR compliance. Ensure adherence to company policies and procedures through document review. Develop and maintain a thorough understanding of regulatory requirements for pharmaceuticals. Provide feedback on document quality and suggest improvements where necessary. Collaborate with cross-functional teams to resolve issues related to document control.

Role & responsibilities 1. Ensure compliance with cGMP, safety, and statutory requirements in warehouse operations. 2. Manage receipt, inspection, storage, sampling, issuance (FIFO), and dispatch of materials. 3. Maintain and review SOPs, GMP records, bin cards, and warehouse documentation (eDMS). 4. Oversee training, task allocation, and performance monitoring of warehouse personnel. 5. Monitor equipment calibration, housekeeping, preventive maintenance, and validations. 6. Track inventory status including non-moving, rejected, and re-test materials. 7. Handle deviations, change controls, CAPA, and risk mitigation activities. 8. Coordinate with QA, QC, R&D, HR, and Engineering to ensure smo...

Job Overview As an R&D/Product Development Engineer, you will be responsible for implementing and growing the capabilities and services of balloons provided by the Components group, primarily with Balloons (extrusion and forming). This will be a fast-paced role where we design new products for new and existing markets, qualify tooling, and specify new capital equipment investments. You will also work alongside with Operations and parallel R&D teams to understand design criteria to optimize quality and maximize throughout. Responsibilities & Required Skills Responsibilities: Implement and grow new technology of Balloons (extrusion and forming) Procure & qualify capital equipment, tooling, and...

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take t...

Key Deliverables: Develop and maintain validation plans and documentation Execute validation protocols aligned with regulatory guidelines (21 CFR Part 11, Annex 11) Support system lifecycle validation including periodic reviews and change management Provide technical support for validated systems and maintain compliance Role Responsibilities: Collaborate with cross-functional teams for high-quality software delivery Conduct risk assessments and define user and functional requirements Ensure operational smoothness and incident handling for validated systems Stay current on technology trends and validation best practices

Role & responsibilities Responsible for documentation related to quality system guidelines. Responsible for maintaining the Company's internal audit program (including quality) and assess improvement initiatives resulting from all Audits internal and external. Monitor activities to ensure compliance with core quality measures. Responsible to close internal and externally identified non-conformities and review the implementation of CAPA plan Represent the management for all external Quality Audits as and when required/directed Conducting the internal audits on timely basis & follow for NCs closure Responsible to visit south warehouses as per management requirement/Customer requirement and rep...

Develop thorough test plans and document the results and progress Develop in-depth functionality and stability automatic tests that will map customer use cases Research the right set of workloads and benchmarks Develop automated test scenarios and environments for End2End automatic evaluation Collect test evidence measurements to ensure system functionality, stability and scalability Establish automatic measures to assess the accuracy Analyze results to find ways to improve functionality coverage Analyze root causes and identify areas for improvement Collaborate with development teams to drive resolution for issues and improvement Generate test automation summary reports for stakeholders rev...

The Project Management Officer (PMO) provides a range of support services to the Engagement Managers to govern our engagements, plan and track them, report progress, manage issues and risks, control change, manage deliverables and quality, track obligations, adhere to our contractual and commercial constraints, manage our finances and keep electronic records of what we produce and do. - Grade Specific A PMO Lead is the Excellent Professional. They are valued for what they bring as an individual skilled PMO practitioner. They will know what works, what doesnt and why.

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications ...

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share wee...

Chemveda is hiring for Quality Assurance Executive Position Experience - 2-6 years Qualification - M.Sc Chemistry /M.Pharma Designation - Executive Job Responsibilities :- 1. Involves in daily QA activities for SOP compliance. 2. Equipment and Software qualifications Review of USR & SRS, Review of IQ, OQ, PQ document inhouse softwares and maintenance of Equipment and software related back up coordination with other departments. 3. Preparation of refresh and QMS Training presentation and circulating training links to all employees based on training schedules and follow ups. 4. Review of Risk assessments related to change control, CAPA, Deviation, OOS, OOT. 5. Review of Analyst Qualifications ...

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (...

Sr. Executive AM- Hot Refining: CMR GreenTechnologies Limited CMR Group is India's largest producer ofAluminium and zinc die-casting alloys. With 13 state-of-the-art manufacturingplants across the country, CMR has become the preferred supplier for many ofIndias largest automotive industry leaders. Since its inception in 2006, CMRhas consistently outpaced competition by focusing on delivering superior valueto its stakeholders. This value is driven by a strong commitment to technicaladvancements, quality enhancement, sustainability, and people-centric practices.We believe in an " Employee First " philosophy, ensuring that our people are at the core of our success. Our dedication tofostering an...

Experience of reviewer data review of method validation. Document review like STP, Protocols and Reports of AMV , verification. Monitoring of daily activities Preparation and review of Validation Protocol, Report, SOP and Specifications, analysis.

Raw Material Inspection. Like Boards, Kraft, Liner, Adhesive, Coating, Film, Etc (Sampling, Testing, Reporting & Recording) In-Process Checking (Printing & Post printing) COA (Certificate of Analysis) making. Lab Instruments Calibration Required Candidate profile Customer Specification Analysis & Comparison Against Actual. Job Traceability (Forward & Backward) Creating Job file like Artwork, KLD, shade card, approved Dummy and Inspected incoming raw materials. Perks and benefits Accommodation, PF, ESI, Bonus