26 Mastercontrol Jobs

About MasterControl: MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information...

Position: IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) Job Summary: The Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5. This role involves planning, authoring, reviewing, and executing validation deliverables, and supporting cross-functional teams. Key Responsibilities: Develop and execute validation strategies and plans for new and existing computerized systems. Create and maintain validation documents including: Ø User Requirements Specifications (URS) Ø Functiona...

Overview Responsible for using mechanical engineering principles to design, develop, customize, implement, test and/or sustain TDW products and services solutions for customer applications. This is an individual contributor role that works independently and with a team of other mechanical engineers and collaborates with individuals from other engineering specialties for finished system or product. Key Responsibilities Primary duties may include, but are not limited to: Applies knowledge of engineering principles to design components, products, tests and systems. Documents design calculations, tolerance analysis, concept development, 3D CAD models, engineering drawings and details design acti...

About MasterControl: MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information...

As part of the Global IT Team, this position will lead the harmonization of Quality Management System (QMS) solutions, from a technology perspective, and the implementation and stabilization of Veeva Vault as a global eQMS software solution, working closely with leadership in the RA/QA organization. On a daily basis, this lead will drive the implementation and support of Veeva Vault as the technology platform enabling a transformation of Bio-Rad’s Quality Management Systems onto a modern, harmonized application that reduces risk, enhances proactive issue detection, standardizes reporting, supports a culture of quality, and is scalable and sustainable for Bio-Rad’s future growth. How The Cand...

Overview Responsible for using mechanical engineering principles to design, develop, customize, implement, test and/or sustain TDW products and services solutions for customer applications. This is an individual contributor role that works independently and with a team of other mechanical engineers and collaborates with individuals from other engineering specialties for finished system or product. Key Responsibilities Primary duties may include, but are not limited to: Applies knowledge of engineering principles to design components, products, tests and systems. Documents design calculations, tolerance analysis, concept development, 3D CAD models, engineering drawings and details design acti...

Description At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—t...

Description At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—t...

About MasterControl: MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information...

About MasterControl: MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information...

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate...

Actylis is a global solutions provider with over 75 years of experience, specializing in streamlining the management of critical ingredients and raw materials for our business partners. We offer both sourcing and manufacturing solutions tailored to meet diverse and evolving needs, ensuring a reliable, agile, and secure supply network. Our commitment to customization allows us to create flexible solutions, whether it’s a unique specification, custom packaging, or tailored logistics strategies. With deep expertise in quality and regulatory compliance, sourcing and logistics management, analytical services, and R&D support, we reduce complexities and mitigate risks, empowering our partners to f...

At TDW we put people first - that means working everyday to ensure the pipelines that run through our communities are operating safely and reliably. What sets us apart is our expertise, experience and commitment. Each day we dedicate ourselves to treating each other, our customers and our community with care and respect. Overview Responsible for using mechanical engineering principles to design, develop, customize, implement, test and/or sustain TDW products and services solutions for customer applications. This is an individual contributor role that works independently and with a team of other mechanical engineers and collaborates with individuals from other engineering specialties for fini...

Company Overview: One Vector is a rapidly growing IT professional services startup specializing in AI/ML, Data Science, Analytics, IT Quality/Compliance, and Pharmacovigilance for biotech companies. Our mission is to empower biotech organizations with cutting-edge solutions and expert insights to drive their success. As we continue our rapid expansion, we are seeking a dynamic and experienced Computer System Validation (CSV) Specialist to join our team. Position Overview: We are seeking a highly skilled and motivated Software Validation Engineer professional to lead and support the validation lifecycle of GxP regulated computerized systems. In this client-facing role, the ideal candidate wil...

Company Description zipp.ai is building AI to improve Food & Drug Quality. We are revolutionizing Quality & GxP compliance for Pharma and Food industries. Our mission is to ensure 100% compliance with Good Manufacturing Practices (GMP) by proactively detecting deviations and analyzing process gaps. We provide innovative solutions to tackle quality and compliance challenges faced by manufacturers, leveraging advanced technology and AI to enhance product quality and operational efficiency. Why Join zipp.ai? Foundational Role: Be one of the first implementation experts in a growing company, with the opportunity to define our customer onboarding and success playbook. High Impact: Your work will ...

Documentation Specialist in a clinical research organization Location: City: Hyderabad Department: Regulatory bodies / Quality Assurance / Ethics Committees Reports To: Head of Department Employment Type: Full-Time Gender: Male Job Summary: The Documentation Specialist is responsible for managing, organizing, and maintaining regulatory, clinical, and operational documents in compliance with applicable guidelines and company SOPs and license conditions. This role ensures accuracy, completeness, and timely availability of critical records to support audits, inspections, and operational continuity. Key Responsibilities: Develop, format, and maintain controlled documents (SOPs, protocols, study ...

Position Summary The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department, overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The SRA supports the department by managing the organization of regulatory documents for submissions, , ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes, mentor team members, and coll...

Position Summary The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory ...

Identify/implement process improvement initiatives using Lean,Six Sigma,Kaizen methodologies. Analyze performance metrics/lead root cause analysis (RCA)/corrective action plans. Collaborate cross-functionally to reduce waste/increase efficiency. Required Candidate profile 3--7 years of experience in a quality or process engineering role. Strong understanding of ISO 9001, IATF 16949, and APQP. Hands-on experience with quality tools (5 Why, Fishbone, SPC, MSA, etc.).

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory...

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate...

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5565 Position Summary: The Senior Regulatory Administrator (SRA) provides essential administration and operational support to the Regulatory Affairs department, overseeing the efficient management and maintenance of regulatory documents within the regulatory systems. This role is pivotal for ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The SRA supports the department by managing the organization of regulatory documents for s...

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5566 Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulation...

Responsibilities: a) Provide L1 & L2 technical support for QUMAS users, resolving system issues, access problems, and workflow errors. b) Troubleshoot performance issues, integration errors, and system security vulnerabilities related to QUMAS. c) Work with IT teams to resolve server, database, and network-related issues affecting QUMAS functionality. d) Monitor QUMAS performance, uptime, and security to ensure system reliability. e) Perform software updates, patches, and system configurations as needed. f) Manage user accounts, roles, and access permissions following security and compliance guidelines. g) Monitor electronic signatures, audit trails, and data integrity within the QMS platfor...

Position Summary: The Regulatory Administrator (RA) provides essential administrative and operational support to the Regulatory Affairs department to facilitate the regulatory submissions process. This role is critical to ensuring that regulatory documentation is accurate, compliant, and submitted in a timely manner to regulatory bodies such as the FDA, EMA, and other international authorities. The RA supports the department by managing regulatory submissions, organizing documentation, and ensuring compliance with relevant guidelines and regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory...