1114 Change Control Jobs - Page 6

Overview The Enterprise Operations and Quality team oversees the data, services, and applications within the Climate and Sustainability Engineering and MSCI's Data Technology verticals. Our primary responsibility is to manage and support end-to-end Quality Engineering by creating tools and tests that ensure continuous quality assessment of applications, services, and generated data. MSCI is renowned for its high-quality data, which is crucial for critical investment decisions, and our role is vital to this mission. Responsibilities Develop and implement engineering solutions to address complex data validation challenges. Develop code in Python and/or Java to maintain high-quality data integr...

Job Description Summary Become part of a winning team and help to deliver the Green Energy transition. As a Global Verification and Validation Manager, you will be responsible for managing a team of product specialist that will be working across the Engineering Delivery function, NPI and Product Care function reporting directly to the Head of Control and Protection Verification & Validation Engineering Leader. This role includes developing department talent, engineering process management, provide technical guidance, mentoring, drive consistent design practices, tools and common global processes for projects implementation and provide technical solution that meets the needs of NPI, Product C...

Who We Are Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with. How You...

You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, ...

About Oracle Advanced Customer Services Oracle Advanced Customer Services is dedicated to providing high-quality support to over 6,000 companies across 100 countries, ensuring that their unique requirements and business goals are met. By collaborating with customers to understand their needs, Oracle Advanced Customer Services assists them in adopting the right technology to shape their future and achieve their objectives. When business continuity is essential, Oracle Advanced Customer Services offers proactive guidance and preventative services through a dedicated support team. This team focuses on driving high availability across the entire Oracle IT stack, covering applications, middleware...

You will be responsible for reviewing the production plan and coordinating among demand planning and supply planning teams. You will need to circulate the plan to the respective Contract Manufacturing Organization (CMO) and ensure its execution as per the requirement. Creating purchase orders and circulating them to the respective CMO for production planning will be a part of your responsibilities. You will support the monthly sales closing for the assigned business domain, ensuring the delivery of all committed products for that respective month. You will be coordinating with the Supply Planning team for the logistic management of finished goods from CMO to the principal warehouse. Proactiv...

As the overseer of PMO services, you will be responsible for governance, project delivery, RAID management, change control, resource planning, and financial management. Your role involves managing Steering Committees, preparing meeting minutes, and tracking key project activities. It will be your duty to drive the end-to-end phases of project delivery, ensuring timely completion within budget constraints. You will also be expected to implement Agile methodologies, including Dashboards, QBRs, sprint planning, and PI planning. Collaboration with stakeholders to ensure alignment with business goals and deliverables is crucial. You should be adept at handling scenario-based questions and providi...

You will be responsible for preparing and reviewing validation documents such as Area Qualification for new facilities, Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Control System Qualification, commissioning, validation & re-qualification, and Revision Qualification for equipment/utilities/facilities. You will generate reports that summarize results, specifications, and acceptance criteria. Your role will also involve authoring documents in ValGenesis. In addition, you will track SOPs due for review, circulate them for comments, update comments, initiate change control, initiate ERA workflow, and follow up fo...

As a Technical Support Specialist at Amneal Pharmaceuticals, you will be responsible for providing end-to-end coordination for all R&D projects in a variety of areas including product initiation, API sample evaluation, product development, ANDA submission, FDA queries, ANDA approval, and launch. Your role will involve collaborating with API suppliers and internal technical teams such as Analytical, Formulation, Regulatory, and QA/QC to address technical concerns, document issues, material quality, and meet requirements for ANDA submission and regulatory agency approvals. You will utilize your technical knowledge to conduct detailed reviews of API drug master files according to current US FDA...

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of e...

Global Study Centre (GSC) is looking for Documentation Assistant to join our dynamic team and embark on a rewarding career journey Prepare, organize, and manage company documentation and records. Ensure documents are properly filed, easily accessible, and securely stored. Assist in the creation and revision of company policies, procedures, and manuals. Coordinate with various departments to gather and verify documentation. Maintain documentation databases and ensure data integrity. Prepare reports and summaries as needed for management review. Candidates of with proficiency in English and work experience are preferred. Freshers can be applied for the post of trainees.

Job Description Summary Join a global leader in energy transmission and help shape the future of power. We are looking for a Senior Project Engineering Manager to lead the engineering execution of large-scale EPC projects from our Noida office. You will oversee a diverse, international team and drive the successful delivery of engineering scopes on high-impact energy infrastructure High Voltage Direct Current (HVDC) substation 1-2B$+ projects. This candidate will work in a rapidly growing energy market including India in contributing to sustainable energy solutions in emerging economies. Further posing good understanding of local regulations and standards, which can differ significantly from...

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 : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Mechanical Engineering Practitioner, you will d...

As a Manager 1 at Sun Pharma Laboratories Ltd in Guwahati - Regulatory Affairs, your primary responsibilities will include: - Facilitating the harmonization and consistent implementation of Quality System and procedures at the site in alignment with Corporate Quality Policies/Procedures. - Reviewing documents related to Quality Management System (QMS) & Compliance. - Ensuring compliance of the Quality Management System. - Participating in Site Training Programs as per site and Global Quality Standards requirements. - Submitting Dossier documents after review against requests received from Corporate regulatory affairs. - Responding to queries related to submitted dossiers as per requests from...

As a professional in the field of Quality Assurance, you will be responsible for various key tasks to ensure compliance with regulatory standards and the maintenance of high-quality systems. Your expertise in FDA GMP audits will be essential in guaranteeing adherence to regulatory requirements. Additionally, your experience in establishing and overseeing Quality Management Systems (QMS) will play a crucial role in maintaining compliance with GLP and cGMP standards. Your proficiency in creating, reviewing, and maintaining Standard Operating Procedures (SOPs) will be vital in ensuring consistency and efficiency in processes. You will also be tasked with managing and implementing change control...

Sr. Executive- Talent Acquisition is responsible for driving the recruitment team to meet and exceed hiring targets within defined timelines while ensuring process adherence, data accuracy, and high-quality delivery. The role demands strong leadership to manage team productivity, skill development, and performance enhancement. This individual will work closely with TA vertical leads to execute strategic hiring plans, foster diversity hiring, and streamline recruitment processes for better efficiency and stakeholder experience. Key responsibilities include monitoring and reporting performance metrics (SLA, source mix, compliance, quality), promoting effective communication within the team, en...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to b...

This role is responsible for leading a project team in delivering a solution to the client using the appropriate business measurements and terms and conditions for the project according to the project charter, project agreement or contract. They have overall performance responsibility for managing scope, cost, schedule, and contractual deliverables, which includes applying techniques for planning, tracking, change control, and risk management. They are responsible for managing all project resources, including subcontractors, and for establishing an effective communication plan with the project team and the client. They provide day to day direction to the project team and regular project stat...

Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on ...

Position- Executive/Sr. Executive Dept.-Regulatory Affairs Key Responsibilities Act as the first point of support for Business Development Managers on product-related queries from India. Coordinate and organize audits of supplier production facilities to ensure compliance with international standards. Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM). Understand and translate client quality parameters for raw materials, ensuring supplier adherence. Monitor supplier manufacturing processes for compliance with national and global standards. Assist in preparing and managing documentation for specification setting, change controls, regulatory submissi...

About The Role 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. * 1+ years of experience as PMO * Strong in advanced MS office suites * Management of complex calendar and scheduling. * Track and drive completion of key deliverables * Maintaining and tracking headcount information * Onboarding and offboarding of team and replicon management * Ability to liase ...

About The Role We are seeking a skilled and experienced MES Engineer with hands-on expertise inKrber Werum PAS-Xto support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have a strong technical foundation, validation knowledge, and excellent communication skills to effectively bridge the gap between technical teams and business stakeholders. Key Responsibilities:- MBR Design & Development: Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes. Analyze site-specific requirements and translate them into functional MBRs. Validate MBRs for deployment across manufacturi...

Job Summary The Policy Servicing Specialist will be responsible for managing and maintaining life and annuities insurance policies. This role requires a keen eye for detail and proficiency in MS Office to ensure accurate policy servicing. The candidate will work in a hybrid model primarily during day shifts with no travel required. The role is crucial in supporting the companys mission to provide exceptional insurance services. Responsibilities Manage and maintain life and annuities insurance policies to ensure accuracy and compliance with company standards. Utilize MS Office tools to efficiently process and update policy information. Collaborate with internal teams to resolve policy-related...

Role & responsibilities 1. Managing the quality documents and conducting internal Audit & data review etc. 2. Maintaining all records and documentation as per 17025:20053. 3. Maintaining regularly and tracked calibration and standard log books, 4. Directing all quality activities for the laboratory such as ILC, IQC, Training, etc. 5. Preparing compliance report for the audit or for the closure of various shortcomings or NCs. 6. Having sound knowledge of QMS and LIMS. 7. Knowledge of 21cfr, OOS, Market complaints, APQR.