46 Mastercontrol Jobs

Job Title: Quality Management System (QMS) Specialist Company Name: Sansera Engineering Job Description: Sansera Engineering is looking for a skilled Quality Management System (QMS) Specialist to join our team. The ideal candidate will be responsible for developing, implementing, and maintaining the quality management system in accordance with industry standards and regulatory requirements. You will work closely with various departments to ensure compliance and drive continuous improvement initiatives. Key Responsibilities: 1. Develop, implement, and maintain QMS documentation, including quality manuals, procedures, and work instructions. 2. Conduct internal audits to assess compliance with ...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

Technical Writer – Quality & Manufacturing Documentation (India, supporting U.S. Operations) 📍 Mumbai, India | Full-Time | On-site (with U.S. overlap) Hubot, Inc. (CDMO) — a fast-growing contract development and manufacturing organization specializing in liquid and aerosol filling for personal care and pharmaceutical brands — is hiring a Technical Writer to support our U.S. operations . This role owns the authoring, editing, and QA-grade review of production and quality documentation, ensuring our records are clear, compliant, right-first-time , and ready for release. You will collaborate daily with U.S. Quality, Manufacturing, R&D, and Supply Chain teams to draft, revise, and approve specif...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

Job Title: Engineering Documentation Specialist Sterile Injectable Facility (Remote India) Department: Engineering / Technical Operations Reports To: Associate Director of Engineering / Director of Engineering (U.S.) Location: Remote (India) Supporting U.S.-based pharmaceutical injectable manufacturing facilities Position Overview: The Engineering Documentation Specialist will be responsible for creating, maintaining, and managing all engineering-related documentation for sterile injectable manufacturing facilities operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring technical accuracy, regulatory compliance, and timely documentation of engineering a...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

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,...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

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...

Role Description Job Description: Associate III – Business Analysis (Regulatory Affairs – Life Sciences Publishing) Role Summary The Associate III – Business Analyst (Regulatory Affairs – Publishing) plays a crucial role in supporting regulatory operations within the life sciences industry. This role involves understanding stakeholder needs, gathering and analyzing requirements, and assisting in the creation and maintenance of regulatory submission documentation. The associate is also responsible for publishing regulatory submissions in compliance with global health authority standards and guidelines, under guidance from Senior BAs and Regulatory Leads. Key Responsibilities Business Analysis...

Role Description Role Proficiency: Analyse the business needs of the stakeholder(s) across the engagement. Understand and use the various BA tasks required to be performed as required by the engagement usually with a good assistance from senior BAs. Outcomes Assist Leads to understand and define enterprise goals and objectives Tailor the business approach based on the audience’s known preferences/needs Adapt the preferred verbal & non-verbal communication style to the needs of the situation and the individual Apply system analysis techniques to analyze requirements system capabilities workflows and functional limitations Assess the complexity and size of the change and the overall risk facto...

Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams. Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compli...

Job Description: Senior Consultant Pharmaceutical QMS GxP We are seeking a highly experienced IT Consultant 10 years to lead the design and implementation of Quality Management Systems QMS in GxP regulated pharmaceutical environments This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance As a key member of our Life Sciences R D consulting team you will play a pivotal role in delivering scalable compliant QMS solutions You ll lead quality initiatives facilitate cross functional workshops and help shape global quality processes aligned with regulatory standards such as ICH FDA EMA MHRA ...

As a Mechanical Engineer at TDW, your role involves designing, developing, customizing, implementing, testing, and sustaining TDW products and service solutions for customer applications. You will work independently and collaborate with a team of mechanical engineers and other engineering specialties to deliver finished systems or products. Key Responsibilities: - Apply engineering principles to design components, products, tests, and systems. - Document design calculations, tolerance analysis, concept development, 3D CAD models, engineering drawings, and design activities. - Assist in creating product documents like build and operating/maintenance manuals. - Complete engineering change requ...

Job Title: Engineering Documentation Specialist – Sterile Injectable Facility (Remote – India) Department: Engineering / Technical Operations Reports To: Associate Director of Engineering / Director of Engineering (U.S.) Location: Remote (India) – Supporting U.S.-based pharmaceutical injectable manufacturing facilities Position Overview: The Engineering Documentation Specialist will be responsible for creating, maintaining, and managing all engineering-related documentation for sterile injectable manufacturing facilities operating under FDA 503B or cGMP environments. This position plays a critical role in ensuring technical accuracy, regulatory compliance, and timely documentation of enginee...

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 Functional ...

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,...

Role Description Role Proficiency: Analyse the business needs of the stakeholder(s) across the engagement. Understand and use the various BA tasks required to be performed as required by the engagement usually with a good assistance from senior BAs. Outcomes Assist Leads to understand and define enterprise goals and objectives Tailor the business approach based on the audience’s known preferences/needs Adapt the preferred verbal & non-verbal communication style to the needs of the situation and the individual Apply system analysis techniques to analyze requirements system capabilities workflows and functional limitations Assess the complexity and size of the change and the overall risk facto...

Role Description Job Description: Associate III – Business Analysis (Regulatory Affairs – Life Sciences Publishing) Role Summary The Associate III – Business Analyst (Regulatory Affairs – Publishing) plays a crucial role in supporting regulatory operations within the life sciences industry. This role involves understanding stakeholder needs, gathering and analyzing requirements, and assisting in the creation and maintenance of regulatory submission documentation. The associate is also responsible for publishing regulatory submissions in compliance with global health authority standards and guidelines, under guidance from Senior BAs and Regulatory Leads. Key Responsibilities Business Analysis...

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...