1114 Change Control Jobs

Executive Regulatory Affairs (Europe Market) – Ahmedabad | M.Sc./B.Tech | 3–5 yrs exp. | Prepare & review eCTD dossiers, manage DMFs, submissions, change controls, ensure EMA/USFDA/ICH compliance, coordinate cross-teams, expertise in eCTD software.

Role & responsibilities Sampling and analysis of Raw Materials, In-process samples, Finished Products , and Stability samples as per SOP and test methods. Preparation and standardization of volumetric solutions, reagents , and reference standards . Performing routine chemical, instrumental (HPLC, GC, UV, FTIR), and microbiological testing (for applicable roles). Equipment/instrument calibration and maintenance logs. Participation in method validation , stability studies, and process validation activities. Adherence to Good Laboratory Practices (GLP) and regulatory standards. Supporting internal and external regulatory audits (like USFDA, WHO-GMP). Reporting deviations, OOS results, and non-c...

Role Description The Financial Operations Analyst reports to and works closely with the Service Lines Regional and National Financial Operations Leaders, as well as within the firms other core Finance functions (Centralized Billing, Planning & Investment, Enterprise Reporting & Analytics) to provide consistent and collaborative support and analysis. The role requires strong analytical and communication skills and the ability to support multiple leaders simultaneously. Areas of Responsibility: Support our client-facing professionals to optimize engagement efficiency and profitability through active project management (a thorough understanding of the business of our business is paramount); thi...

Role & responsibilities Responsible for the control and maintenance of all laboratory documents. Ensure adherence to the Quality Policy and compliance with ISO/IEC 17025 requirements. Prepare and maintain updated lists of certified reference standards and working standards. Conduct induction training sessions for newly joined laboratory personnel. Review and verify analytical test reports to ensure accuracy and compliance with established standards. Prepare and regularly update the SOP/STP list, equipment list, and calibration schedules for all laboratory equipment. Develop and maintain preventive maintenance schedules for laboratory equipment. Prepare and update training schedules as per th...

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...

• Assigning batch details • Preparing the batch CoAs • Keeping the entry of Inward and Outward details • Regulatory market review or our products and verify guidelines Required Candidate profile Candidates with excellent knowledge in COA, Batch Details, Batch Record, Vendor qualification, CAPA, Customer Query resolution.

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. Youll find an environment that inspires and empowers you to thrive both personally and professionally. Theres no one like you and thats why theres 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 man...

As a Project Coordinator within the Finance Team at our global energy business, you will play a crucial role in coordinating and executing various business engagement activities. Your responsibilities will include: - Assisting the Business Engagement Manager in planning, coordinating, and performing all engagement activities. - Serving as the primary point of contact for customers involved in engagements. - Preparing reports, presentations, and briefing materials for meetings and engagements. - Facilitating communication between business teams, external partners, and leadership. In addition to these key responsibilities, you will also be involved in: - Planning and coordinating business visi...

Role Overview: You will be a part of the Door Trim team within Body Engineering, focusing on the design and development of Interior components for new or ongoing Program Development (OPD) programmes. Your main responsibility will be to lead the engineering design, technical development, and delivery of Interior components, ensuring timely launch at the Manufacturing plant while maintaining the integrity of the Cabin and vehicle systems. Key Responsibilities: - Lead the engineering design, technical development, and delivery of Interior components - Deliver the commodity plan to quality, cost, and time - Own and deliver the Engineering Advanced Product Quality Planning deliverables - Manage C...

Role & responsibilities Job Purpose To ensure compliance of OSD packing operations with regulatory and company quality standards, by managing QMS activities such as deviations, change controls, CAPA, documentation, and audits. Key Responsibilities Ensure packaging operations are carried out as per cGMP, SOPs, and regulatory guidelines. Handle QMS activities related to packaging, including: Deviation management Change control CAPA implementation and follow-up Document review and approval (SOPs, protocols, batch records) Review and maintain packaging batch records and logbooks. Coordinate with production, QA, and engineering teams for compliance requirements. Assist in investigation of market ...

Role Overview: Myers-Holum is expanding operations to Bangalore, India, and is actively seeking an experienced Delivery Manager to play a pivotal role in the rollout of operations, recruiting, hiring, and driving the growth and deliverables of the new office. As a Myers-Holum Delivery Manager, you will play a dual role as a player-coach, providing day-to-day support to a team of direct reports while managing a small client portfolio of engagements. Your success in this role will depend on your ability to prioritize tasks, offer support in escalations, solution architecting, and recruiting, ensuring that priorities are met and handled efficiently. You will not only manage your team but also i...

**Job Title: Module Lead - Technical** **Company: Happiest Minds** **Location:** Bangalore **Job Type:** Full-time **Experience Required:** 5 to 8 years --- ### **Job Description:** Happiest Minds is seeking a highly skilled and motivated Module Lead - Technical to join our dynamic team. The ideal candidate will possess a strong background in Natural Language Processing (NLP), Automation Anywhere, and AI Prompt & Response, and will be instrumental in leading technical modules and ensuring project success through innovative solutions. ### **Key Responsibilities:** - Lead the design, development, and implementation of NLP-based solutions, ensuring high-quality outputs that meet client requirem...

As an R&D Engineer, youll collaborate closely with Scrum Masters and Product Owners to bring innovative features to life and resolve defects with precision. Youll craft robust unit, integration, and automation tests to ensure top-tier product quality, and partner with documentation teams so customers can seamlessly use new capabilities. This role is a hands-on journeyimmersing you in cutting-edge technologies, agile processes, and the full SDLCwhere youll take on growing responsibilities while mastering skills that shape next-generation products and solutions. You have: A graduate or postgraduate in Engineering or an equivalent degree, with strong programming and problem-solving abilities an...

RESPONSIBILITIES May perform one or more of the following: Requirement/Analysis Ability to comprehend Business Requirement Documents (BRD) Maintain and Update Data/Vendor Interfaces BRD Interprets requirements to create systems specifications documents to build and execute system. Perform Data Analysis, Audit, and associated research and provide subsequent resolutions. Understanding of database/SQL Query Writing Work alongside with Sr. members or individually (as required) to assist in smooth integration/transition of processes and create/maintain documentations for the same. Responsible for solving the data and Vendor files related issues and preparation of annual calendar, as applicable. E...

Work with Us. Change the World. At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world’s most complex challenges and build legacies for future generations. There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital ...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

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...

Set up bolus compression machines acc. to production specifications, Adjust machine settings, Identify & report mechanical issue, Load raw materials (powder/granules) into the machine hoppers, Maintain accurate production logs.

About The Role Position Summary Looking for experienced TFA Administrators to support the overall growth of the organization. This position will be primarily responsible for deploying software products to production environments, that are designed to increase the value of customers to the Bank Summary Essential Job Functions Responsible for managing an existing TFS system and deployment automation Responsible for the deployment orchestration to multiple environments for multiple products. Responsible for creating and maintaining application and system configuration files. Responsible for release branching and release maintenance Responsible for application deployment enhancement. Performs ot...

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing (Executive/Senior Officer / Officer) Experience - 02 to 08 Years Qualification - B. Pharmacy/ M Pharmacy / Msc / Bsc / Engineering - (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech QUALITY ASSURANCE IPQA (injectable) / QMS / Documentation (Officer / Senior Officer /...

Job Purpose We are looking for a qualified IT QA professional to support the implementation, validation, and compliance of electronic systems in accordance with global regulatory standards. The role ensures the effective functioning of key systems like TrackWise, AmpleLogic, LIMS, SAP, and eLMS while driving data integrity, compliance, and quality excellence across business operations. Roles & Key Responsibilities Ensure implementation and compliance of electronic systems (TrackWise, AmpleLogic, LIMS, SAP, eLMS, MES) as per global regulatory guidelines (USFDA, EU, WHO, PMDA, CDSCO, etc.). Review and support validation/qualification of software (DQ, IQ, OQ, PQ), ensuring timely closure of pro...

Handling Quality management system and regulatory support & reviewer. Change control, CAPA,OOS,APQR. Compliance verification at Site. Dispatch compliance. BMR and Work sheet compliance before release. Document and Data control and training.

Quality Management System (QMS): Implement and maintain QMS in line with cGMP and regulatory requirements. Review and control SOPs, specifications, master documents, and records. Ensure timely execution and closure of change controls, deviations, CAPA, and risk assessments. Support continuous improvement initiatives in QMS processes. Audit & Compliance: Prepare and participate in internal, external, customer, and regulatory audits (e.g., USFDA, MHRA, WHO, EU). Ensure audit observations are tracked, addressed, and closed within timelines. Conduct periodic self-inspections to ensure plant-wide compliance. Document Control: Manage issuance, retrieval, archival, and control of GMP documents. Ens...

Role Overview: You will be responsible for supporting the vision and roadmap for maturing Process Management for the client, aligning with their strategic initiatives. You will also assist in the design and execution of process management activities by the Process Centre of Excellence, including Process Governance, Change Control, Quality Control, and Continuous Improvement. Additionally, you will contribute to the implementation and standardization of process management and process excellence across the client's organization. Collaboration with Process Owners, Technology, Data, Risk, and other departments will be essential to continuously improve the client's processes through process re-en...

Roles and Responsibilities For IPQA BMR review. To ensure the line clearance to the production unit. To ensure all QA activities are carried out as per the Standard operating procedure. Issuance, Retrieval, Approval & Controlling of all Quality related Documents (i.e. CSOP, SOP, STP, GTP, Protocol, etc.) Preparation, Review, and Retrieval of SOP. Candidate must have relevant experience in IPQA API Industries. Should have good communication and interpersonal skills. For QMS Direct involvement in Deviation and Process Investigation. Handling of Change Control, Process Validation, Qualification, APQR, and Trend Report. Handling Market Complaints, Audit Compliance Reports & QMS-related activitie...