1740 Change Control Jobs - Page 18

The AIN Sr Associate QA plays a critical role in supporting disposition related tasks across the Amgen Quality Operations Network. The Senior Associate QA will leverage industry, technical, and quality systems knowledge to provide support of business performance and GMP disposition supporting processes across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen ...

Role Description: We seek a skilled Sr. Associate Validation Analyst to oversee and manage validation activities for AI platforms and solutions. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the AI products follow the required validation processes, documentation, and comply with Amgens standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation and change control activities, including qualification ...

What you will do In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgens Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audit...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM 6 PM loc...

Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens...

The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guideli...

Role & responsibilities To review that all relevant quality management systems of Hosur manufacturing site are implemented and well maintained. To review, monitor and improve Quality performance of Hosur manufacturing site. To promote quality attitude, awareness, and mindset of the site by all proper means including training to the cross functional team members. Implement, audit, and develop quality management system, in line with Global quality policy/ manual and procedures relevant to area. Ensure the required process controls are in place wherever they are necessary. To review that testing and inspection of all raw materials, packaging materials and finished goods are carried out as per d...

What you will do In this vital role as Specialist Business Analyst as part of Operations Generative AI (GenAI) Product team to deliver cutting edge innovative GEN AI solutions across various Process Development functions(Drug Substance, Drug Product, Attribute Sciences & Combination Products) in Operations functions. As part of this role, you both engage with the business users and partners to elicit requirements and perform data analysis and metrics definition activities as part of a product team of key stake holders, data scientists, business analysts, and software engineers. Roles & responsibilities Collaborate with System Architects and Product Managers to manage business analysis activi...

Job Description Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment's. To attend the breakdown maintenance of all Electrical power distribution equipment's like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supe...

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there's nowhere like RSM. Role Profile for the Project Management Discipline The Project Management discipline spans Functional Roles that provide principles, methods, tools, and techniques for effectively...

At NiCE, we don't limit our challenges. We challenge our limits. Always. We're ambitious. We're game changers. And we play to win. We set the highest standards and execute beyond them. And if you're like us, we can offer you the ultimate career opportunity that will light a fire within you. So, what's the role all about A Program Manager is a key role in organizations, responsible for overseeing and managing multiple projects that are usually interconnected or align under a larger organizational goal. The role of a Program Manager involves planning, coordinating, and executing strategic initiatives that involve cross-functional teams and multiple stakeholders. How will you make an impact Exc...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Principal Software Engineer, Embedded Software will be a member of the Medtronic R&D software team working on product development and support of capital platform products. Principal Software Engineer is considered an expert in embedded software development including the understanding of how software interacts with hardware and FPGAs. The position is a hands-on development role with a dynamic set of responsibilities in a complex sof...

Job Title Sr Executive/Manager 2 Business Unit Sun Global Operations Job Grade G11B/G11A Location : Guwahati 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 Responsible for Receipt of Raw, Packing & Misce...

Job Title DGM Operations (Sterile) Business Unit Sun Global Operations Job Grade G8 - DGM Location : Halol Key Responsibilities 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 Approving sign authority for...

Description Position at Wind River Lead Software Quality Assurance Engineer BANGALORE |INDIA WIND RIVER In a world increasingly driven by software innovation, Wind River is pioneering the technologies to accelerate the digital transformation of our customers with a new generation of Mission Critical AI Systems in an AI-first world with the most exacting standards for safety, security, performance, and reliability. Wind River is a global leader in delivering software for mission-critical intelligent systems. For more than four decades, the company has been an innovator and pioneer, powering billions of systems that require the highest levels of security, safety, and reliability. Wind River he...

Role & responsibilities Manufacturing area:- Line clearance before start of batch processing and after cleaning. In-process checks during manufacturing stages Verification of machines settings, process parameters and yield reconciliatoin Sampling of in-process materials for testing. Monitoring of environmental conditions and compliance during production Verification of online entries in BMR Packing area: Line clearance before start of packing and after product/pack change over. Monitoring batch coding, overprinting, labeling, and packaging operations Performaning in-process checks - correct packing components, label reconciliation, and proper sealing. Monitoring controlled area discipline, g...

Here is how, through this exciting role, YOU will contribute to BMC's and your own success: You like to develop, design, and deliver solutions that deliver sustained business value from our and associated solutions You enjoy working cross-functionally across Sales, Marketing, Operations, and IT organizations for supporting the customer success organization Youre a team player and believe in building synergies across BMC to create/continually evolve one integrated customer journey You like to innovate, and have an appetite for solving business problems, to continuously improve our quality of service You have a passion for development, and challenge yourself to learn new things You know how to...

Job Description Maintenance of GLP in the Laboratory Upkeep of Housekeeping in the Laboratory. Ensuring activity logs are maintained for all critical instruments /equipment’s. Timely preparation of Laboratory Documents. Timely review of analytical data generated in laboratory. Ensuring Analytical Technology transfer from transferring lab as per approved protocol. Review and approval of incident , out of specification ,out of trend report and approval of QC related activities. Involved in QAMS activities such as change control, CAPA , incidents, deviation etc. Approval of stability summery report. Timely review of Quality control procedures and initiation for up gradation of same. Compliance ...

Job Description As a Manager at Lupin Limited, positioned within the Mechanical (Unit I) division at our Pithampur facility, you will take the helm of our engineering operations, spanning the Mechanical, Electrical, and Instrumentation domains. Your role will be pivotal in ensuring the seamless functioning and reliability of pharmaceutical process equipment used in both formulation and active pharmaceutical ingredient (API) production processes. You will be responsible for the strategic oversight and execution of both preventive and breakdown maintenance activities, ensuring minimal downtime and optimal equipment performance. This will involve coordinating comprehensive maintenance schedules...

Project management skills as an Water system & HVAC Engineer. Installation, Execution & maintaining, repairing heating ventilation, air conditioning, water air quality in buildings. HVAC, Water system – QMS Deviation and Change control work. Required Candidate profile SAP – PR and Service entry work in Project Management system.

Roles and Responsibilities 1. Responsible for implementation & monitoring of cGMP/GDP practices at site. 2. Responsible for periodic review of all quality Documents for appropriateness. 3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA. 4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities. 5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups. 6. Responsible for co-ordination and submission of Quality documents for regulatory submissions. 7. Responsible for maintenance, periodical update and review of technical agreements with dome...

Role Overview: You will be responsible for ensuring the establishment, implementation, and maintenance of processes needed for the Quality Management System at the company. Reporting on the quality system's performance to the Head-QA for review and improvement will be a key part of your role. Additionally, you will plan and execute clinical activities, conduct audits, review equipment maintenance, data analysis, and support regulatory inspections. Key Responsibilities: - Ensure establishment, implementation, and maintenance of processes for the Quality Management System. - Report on the performance of the quality system to the Head-QA and suggest improvements. - Plan and execute clinical act...

As an Associate Database Administrator at NTT DATA, you will be an entry-level subject matter expert responsible for assisting in daily database administration tasks. Your role will involve tasks such as database monitoring, backup and recovery, user management, and data maintenance. You will work closely with Change Control, Release Management, Asset and Configuration Management, and other teams to establish user needs and ensure database security. - Assist with the installation, configuration, and maintenance of database management systems (DBMS) like SQL Server, Oracle, MySQL, etc. - Collaborate with software developers/architects to design and optimize database schemas and data models. -...

As a candidate for this role, you will be responsible for various tasks related to self-hygiene and the sterile manufacturing department. Your key responsibilities will include: - Updating on self-hygiene - Preparation, review, revision, control, and implementation of standard operating procedures - Preparation and review of protocols and reports - Document management including BMRs, BPRs, Master SOPs, etc. - Handling of Change Control, Deviations, CAPA, Investigation - Generating general purchase indents for departmental items - Preparation of production planning on a monthly and daily basis - Preparation of daily production reports - Ensuring validation and calibration status of equipment ...