20 Mastercontrol Jobs

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—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Brief Job Overview This is a hands-on, non-supervisory professional position that supports the important work of USP’s Quality Assurance Activities. The Quality systems Associate is the expert in management of the tool of Quality Management System (MasterControl) including all quality documentation and training with respect to business objectives, provides guidance regarding Document workflow, proof-reading, and accuracy of documents. All Document Control functions must be compliant with applicable ISO Requirements and industry best practices. This position is responsible for managing user accounts, organizing, maintaining, and updating all controlled documents and ensuring training is assigned and executed in a timely manner. The Quality System Associate trains all levels of users in QMS tool and collaborates with all departments to maintain a compliant document management/training system and meet business needs. This position works independently, with minimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company’s QMS tool. The Quality System Associate will drive continuous improvement within the system and create/report metrics regarding document status, priority, change management, training completion, and issue management. This position is also leading/supporting workflow development by utilizing the QMS tool to enhance the quality system and improve the process efficiency. This position is also responsible for performing documentation review/release of lab projects, batch records, and equipment qualification. This position will also support the Global Supplier Quality Management Program. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Quality System Associate has the following responsibilities: Document Control activities (at least 50%) : The Quality System Associate is the QMS tool SME, responsible for managing all aspects of the document management processes, as well as training. Review, edit and format documents, approves document change requests, release approved documents and manages document workflows, including new document, document revision and document obsoletion. Review of Standard Operating Procedures (SOPs) and other documentation, including work instructions, to ensure accuracy and compliance. Manages QMS tool users including activating and deactivating users, assigning appropriate roles per business needs, maintaining/assigning job codes, creation of new hire training infocard and assigning new hire mandatory trainings. Creation of training courses, sessions, and support trainers on updating of class roll. Serves as the MasterControl System Administrator/SME and provides training/guidance to all levels of system end-users regarding processes of document management and training, and QMS tool(s). Resolve issues during trouble-shooting requests. Designs/develops/maintains training courses, instructional materials, and training records for the various levels of system users. Improves and streamlines processes of document management, training, issue management and user management. Develop, improve workflows in the QMS tool to enhance the efficiency of processes. Develops/maintains/reports metrics periodically regarding document management, training, issue management, user management. Identifies negative data trends and escalates immediately as necessary. Tracks/follows up key activities, e.g., miss assigned document review, overdue triennial review, pending/ overdue training tasks, etc. Prioritizes activities by compliance and business requirements Communicates effectively with cross-functional and external stakeholders Coordinate with USP Global Site SME’s and MasterControl Customer Support Team to resolve any application issues/glitches for a quick resolution. Assumes other responsibilities as assigned by Adhere and promote USP core values & DEIB (Diversity, Equity, Inclusion and Belonging) within the department and throughout the organization. Other QA activities (not more than 50%): Review/approve the following QA activities Equipment IQ/OQ/PQ documents Equipment calibration documents Quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions. Review/approval of technical and analytical documents of moderate to high complexity for Reference Standards and/or Analytical Reference Materials (ARM) Batch Records Lab data projects Support the Supplier Quality Management program by conducting supplier evaluations, audits, and supplier performance/metrics. Other assignments as required Who is USP Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Master's degree in Science(M.Sc Chemistry/M.Pharm) with 5-7 years relevant experience in a pharmaceutical industry preferably working in QA Document Control function/Analytical Reviewer role/Quality Control in API or formulations industry. 1-2 years of document control experience in a pharmaceutical, biotech, or other regulated industry Hands-on experience in laboratory, handling of analytical equipment, qualification of analytical equipment, calibration, metrology and other laboratory activities is preferable. Strong computer working knowledge of MS Word, PowerPoint, Excel etc., Demonstrated initiative and ability to work independently while handling multiple tasks, as well as part of a team in a dynamic environment. Must have strong technical writing and proofreading skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents. Ability to clearly communicate, both verbal and written and interface with customers and third parties, and diverse audiences at all levels of the organization. Strong focus on internal and external customer service Additional Desired Preferences Experience in managing QMS tool(s) as an Administrator Understanding of GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory. Excellent written and verbal communication skills including well-developed interpersonal skills used to influence the behavior of others. Any diploma in computers or relevant QA/QC/QMS certifications on document management systems and good documentation practices is an added advantage. Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion. Strong knowledge of MS office tools such as Word, Excel, and power point presentation. Supervisory Responsibilities None Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Brief Job Overview This is a hands-on, non-supervisory professional position that supports the important work of USP’s Quality Assurance Activities. The Quality systems Associate is the expert in management of the tool of Quality Management System (MasterControl) including all quality documentation and training with respect to business objectives, provides guidance regarding Document workflow, proof-reading, and accuracy of documents. All Document Control functions must be compliant with applicable ISO Requirements and industry best practices. This position is responsible for managing user accounts, organizing, maintaining, and updating all controlled documents and ensuring training is assigned and executed in a timely manner. The Quality System Associate trains all levels of users in QMS tool and collaborates with all departments to maintain a compliant document management/training system and meet business needs. This position works independently, with minimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company’s QMS tool. The Quality System Associate will drive continuous improvement within the system and create/report metrics regarding document status, priority, change management, training completion, and issue management. This position is also leading/supporting workflow development by utilizing the QMS tool to enhance the quality system and improve the process efficiency. This position is also responsible for performing documentation review/release of lab projects, batch records, and equipment qualification. This position will also support the Global Supplier Quality Management Program. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Quality System Associate Has The Following Responsibilities Document Control activities (at least 50%) : The Quality System Associate is the QMS tool SME, responsible for managing all aspects of the document management processes, as well as training. Review, edit and format documents, approves document change requests, release approved documents and manages document workflows, including new document, document revision and document obsoletion. Review of Standard Operating Procedures (SOPs) and other documentation, including work instructions, to ensure accuracy and compliance. Manages QMS tool users including activating and deactivating users, assigning appropriate roles per business needs, maintaining/assigning job codes, creation of new hire training infocard and assigning new hire mandatory trainings. Creation of training courses, sessions, and support trainers on updating of class roll. Serves as the MasterControl System Administrator/SME and provides training/guidance to all levels of system end-users regarding processes of document management and training, and QMS tool(s). Resolve issues during trouble-shooting requests. Designs/develops/maintains training courses, instructional materials, and training records for the various levels of system users. Improves and streamlines processes of document management, training, issue management and user management. Develop, improve workflows in the QMS tool to enhance the efficiency of processes. Develops/maintains/reports metrics periodically regarding document management, training, issue management, user management. Identifies negative data trends and escalates immediately as necessary. Tracks/follows up key activities, e.g., miss assigned document review, overdue triennial review, pending/ overdue training tasks, etc. Prioritizes activities by compliance and business requirements Communicates effectively with cross-functional and external stakeholders Coordinate with USP Global Site SME’s and MasterControl Customer Support Team to resolve any application issues/glitches for a quick resolution. Assumes other responsibilities as assigned by Adhere and promote USP core values & DEIB (Diversity, Equity, Inclusion and Belonging) within the department and throughout the organization. Other QA activities (not more than 50%): Review/approve the following QA activities Equipment IQ/OQ/PQ documents Equipment calibration documents Quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions. Review/approval of technical and analytical documents of moderate to high complexity for Reference Standards and/or Analytical Reference Materials (ARM) Batch Records Lab data projects Support the Supplier Quality Management program by conducting supplier evaluations, audits, and supplier performance/metrics. Other assignments as required Who is USP Looking For? The Successful Candidate Will Have a Demonstrated Understanding Of Our Mission, Commitment To Excellence Through Inclusive And Equitable Behaviors And Practices, Ability To Quickly Build Credibility With Stakeholders, Along With The Following Competencies And Experience Master's degree in Science(M.Sc Chemistry/M.Pharm) with 5-7 years relevant experience in a pharmaceutical industry preferably working in QA Document Control function/Analytical Reviewer role/Quality Control in API or formulations industry. 1-2 years of document control experience in a pharmaceutical, biotech, or other regulated industry Hands-on experience in laboratory, handling of analytical equipment, qualification of analytical equipment, calibration, metrology and other laboratory activities is preferable. Strong computer working knowledge of MS Word, PowerPoint, Excel etc., Demonstrated initiative and ability to work independently while handling multiple tasks, as well as part of a team in a dynamic environment. Must have strong technical writing and proofreading skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents. Ability to clearly communicate, both verbal and written and interface with customers and third parties, and diverse audiences at all levels of the organization. Strong focus on internal and external customer service Additional Desired Preferences Experience in managing QMS tool(s) as an Administrator Understanding of GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the laboratory. Excellent written and verbal communication skills including well-developed interpersonal skills used to influence the behavior of others. Any diploma in computers or relevant QA/QC/QMS certifications on document management systems and good documentation practices is an added advantage. Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion. Strong knowledge of MS office tools such as Word, Excel, and power point presentation. Supervisory Responsibilities None Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP Job Category Quality Assurance Job Type Full-Time

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, visit www.mastercontrol.com. About the Role We are seeking a highly organized and versatile individual to join our team in Hyderabad India as an HR Representative. In this hybrid role, you'll manage day-to-day office operations while supporting essential HR functions. This position requires an individual who thrives in a fast-paced environment, can manage multiple tasks, and is committed to contributing to a positive workplace culture. Key Responsibilities Office Administration Office Management: Oversee office operations, including supplies, equipment maintenance, and vendor relationships to ensure a smooth workflow. Scheduling & Coordination: Manage meeting room bookings, event planning, and general calendar coordination. Budget Management: Handle office budgets, track expenses, and prepare reports to support efficient resource allocation. Administrative Support: Assist with document processing, filing, and other administrative tasks as needed. Human Resources Recruitment Support: Assist with local recruiting efforts including but not limited to job postings, interview coordination, and onboarding new employees to provide a seamless hiring experience. Employee Relations: Serve as a point of contact for employee inquiries, and support initiatives to promote a positive work environment. HR Documentation: Maintain accurate employee records, manage personnel files, and support compliance with company policies and local labor laws. Training Coordination: Assist in organizing training programs, workshops, and development initiatives. Qualifications Language Skills: Proficiency English (written and spoken) is required Experience: 3+ years in office administration, HR, or a related field, ideally in an international environment. Education: Bachelor's degree in Human Resources, Business Administration, or a related field is preferred. Technical Skills: Proficient in MS Office Suite; experience with HRIS or office management software is a plus. Soft Skills: Strong organizational skills, excellent communication, and a proactive attitude toward problem-solving. Why Work Here? #WhyWorkAnywhereElse? MasterControl is a place where Exceptional Teams come together to do their best work. In fact, hiring Exceptional Teams is a core value of ours. MasterControl employees are surrounded by intelligent, motivated, and collaborative individuals. We like to call it #TheBestTeamOnThePlanet. We work hard to develop and challenge our employees' skillsets, recognize their contributions, encourage professional development, and offer a one-of-a-kind culture. This is why we say #WhyWorkAnywhereElse? MasterControl could be your next (and last) career move! Here are some of the benefits MasterControl employees enjoy: Competitive compensation Schedule flexibility Fitness clubs (you get paid to have fun and be active!) Company parties and employee recognition programs Wellness programs (free Fitbit, gym membership and athletic shoe reimbursements, etc.) Much, much more!

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, visit www.mastercontrol.com. About the Role We are seeking a highly organized and versatile individual to join our team in Hyderabad India as an HR Representative. In this hybrid role, you'll manage day-to-day office operations while supporting essential HR functions. This position requires an individual who thrives in a fast-paced environment, can manage multiple tasks, and is committed to contributing to a positive workplace culture. Key Responsibilities Office Administration Office Management: Oversee office operations, including supplies, equipment maintenance, and vendor relationships to ensure a smooth workflow. Scheduling & Coordination: Manage meeting room bookings, event planning, and general calendar coordination. Budget Management: Handle office budgets, track expenses, and prepare reports to support efficient resource allocation. Administrative Support: Assist with document processing, filing, and other administrative tasks as needed. Human Resources Recruitment Support: Assist with local recruiting efforts including but not limited to job postings, interview coordination, and onboarding new employees to provide a seamless hiring experience. Employee Relations: Serve as a point of contact for employee inquiries, and support initiatives to promote a positive work environment. HR Documentation: Maintain accurate employee records, manage personnel files, and support compliance with company policies and local labor laws. Training Coordination: Assist in organizing training programs, workshops, and development initiatives. Qualifications Language Skills: Proficiency English (written and spoken) is required Experience: 3+ years in office administration, HR, or a related field, ideally in an international environment. Education: Bachelor's degree in Human Resources, Business Administration, or a related field is preferred. Technical Skills: Proficient in MS Office Suite; experience with HRIS or office management software is a plus. Soft Skills: Strong organizational skills, excellent communication, and a proactive attitude toward problem-solving. Why Work Here? #WhyWorkAnywhereElse? MasterControl is a place where Exceptional Teams come together to do their best work. In fact, hiring Exceptional Teams is a core value of ours. MasterControl employees are surrounded by intelligent, motivated, and collaborative individuals. We like to call it #TheBestTeamOnThePlanet. We work hard to develop and challenge our employees' skillsets, recognize their contributions, encourage professional development, and offer a one-of-a-kind culture. This is why we say #WhyWorkAnywhereElse? MasterControl could be your next (and last) career move! Here are some of the benefits MasterControl employees enjoy: Competitive compensation Schedule flexibility Fitness clubs (you get paid to have fun and be active!) Company parties and employee recognition programs Wellness programs (free Fitbit, gym membership and athletic shoe reimbursements, etc.) Much, much more!

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 with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes.

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 focus on growing their business. In furtherance of that goal, Actylis is seeking new members of the team. This expansion, coupled with a comprehensive benefits package, and opportunities for challenge and growth, make Actylis the ideal place to work and thrive. We hope you’ll consider joining us! Location: Actylis Ahmedabad Position summary: The Quality Service Specialist primarily supports commercial and customer quality document requests. Key Responsibilities: Develop Goals and Motivations for Excellence in Quality Support Services: Place the interests of the Commercial Team and the Customer first; our success depends on their success. Be highly responsive and timely to the Commercial Team and Customer Key Accounts. Meet deadlines; communicate status and delays to the Team and customers proactively. Pursue an unrelenting quest for quality; use speed and simplicity to achieve goals. Communicate pleasantly and effectively. Demonstrate professional etiquette and courtesy when interfacing with customers. Conduct oneself with the highest level of integrity and business ethics. Commit to teamwork; seek out and use the ideas and skills of all colleagues. Reach for the highest standards of performance; show a passion for winning. Commercial Team Support Function: Curate any and all Commercial Team and direct Customer Requests: Process information received from Commercial Team personnel via SFDC or the shared email inbox. Manage and prioritize information to ensure timely delivery as per the established SLAs. Organize and maintain documentation received in the Quality sharepoint and/or MasterControl and conduct follow-up, as applicable. Liaise with internal and external stakeholders to resolve customer requests. Complies with and adheres to all regulatory compliance areas, policies and procedures. Identifies and implements “best practices” in Quality Services. Keep all document logs and SFDC task queue up-to-date. Review weekly tasks and responsibilities with direct supervisor. Coordinate the review and signature of CDA/NDAs and QAAs. Coordinate the completion of customer questionnaires, declarations and statements. Update Actylis Statements, Declaration and documents including but not limited to: TSE/BSE, Elemental Impurities, Residual Solvents, GMO, Allergens, Melamine, Prop 65, etc. Respond to Product Information Requests including but not limited to: Specifications, Typical COAs, Certificate of Origin, Test Methods, Shelf-Life Letter, Manufacturer and Supply Chain Information, Packaging Specification/Information, Storage Conditions Statement, Stability Statement, Stability Data, Example Label, etc. Manage product Information packages based on ICH and/or IPEC guidelines. Act as liaison in organizing the timing and set-up of customer audits Qualifications & Experience: Bachelor of Science in Chemistry or related field Quality Systems Knowledge (ISO and GMP) - 2 years experience Industry knowledge preferred Strong communication (oral and written) Accurately apply due dates Meet deadlines Complete tasks Sense of urgency Ability to make sound decisions Ability to multi-tasks Ability to read, understand and apply complex instructions/regulations Stress-management Computer literate Self-motivated, have initiative Analytical Ability to work independently Time-management Attention to detail SUPERVISORY RESPONSIBILITIES: N/A Actylis is an Equal Opportunity Employer. Actylis does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.

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 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 activities. Assists in the creation of product documents (e.g. build and/or operating/maintenance manuals). Completes engineering change requests that provide needed improvements to documentation and design. Estimates durations for application development, assists with prototype assemblies and validation processes and meets deadlines. Assists with test programs, including plan development, running tests and compiling test results and analysis reports. Reports to engineering manager and will work under the guidance of senior engineers. Experience Engineering specific work experience Knowledge, Skills, And Abilities Proficient in 3D modeling, tolerance analysis, GD&T, FEA, and DFMEA. Demonstrated competence with with FEA software (simulation and ANSYS preferred) and solid modeling software (e.g. Siemens NX, SolidWorks, etc) Problem solving skills and understanding of manufacturing processes and machine design principles Understanding of continuous improvement methodologies (e.g. DFM/A, Lean, Six Sigma, etc.) Experience with PLM system, software (e.g. TeamCenter, MasterControl), and engineering change processes Good communication skills - both verbal and written. Competent with MS office

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 will have a strong background in computer systems validation (CSV), quality systems, and Software Development Life Cycle (SDLC) principles. This role is pivotal in maintaining the integrity, reliability, and compliance of digital systems supporting manufacturing, laboratory, and business functions for our clients. This candidate will act as a trusted advisor to our clients, guiding them through the complexities of regulatory compliance while also ensuring the effective implementation and ongoing management of their computerized systems and Lifecycle procedures with Data Integrity requirements. Exceptional communication skills and the ability to forge strong relationships with clients are essential for this role. The successful candidate will be strategic, results-oriented, and committed to driving the company's growth in the biotech sector. Key Responsibilities: Lead validation activities across the full lifecycle of GxP systems including planning, testing, deployment, and periodic review. Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), Validation Reports (VR), and DM (Data Migration) Protocol & Scripts. Oversee vendor qualification assessments and documentation reviews and approvals to ensure third-party systems align with client validation expectations and regulatory standards. Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 Conduct risk assessments for computerized systems to identify potential gaps in compliance. Review and identify validation deviations and resolve deviations with appropriate corrective/ preventive actions Develop validation strategy and documentation for cloud-based and SaaS GxP systems, ensuring alignment with client IT controls, cybersecurity policies, and data residency requirements. Provide Quality Review and Assessment of associated change requests related to processes, IT infrastructure, equipment and computer systems. Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management. Provide recommendations for mitigating risks related to data integrity, security, and system functionality. Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance. Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts. Provide guidance on data integrity principles and ensure alignment with industry standards. Responsible for other duties and projects assigned Qualifications: Required: Bachelor's degree in engineering or scientific discipline. IT Quality Assurance professional with a minimum of 9 years of experience with computerized system validation in Life Sciences industry. Experience validating systems such as LIMS, MES, ERP, QMS, or other laboratory/manufacturing software. Proficiency in authoring, reviewing and executing computer validation documentation (URS, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR). Proven track record of working with regulatory and industry frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC. Ability to work independently and collaboratively across cross-functional teams. Familiarity with audit readiness and experience supporting regulatory inspections or internal audits. Preferred: Master’s degree in a relevant discipline. Experience with QMS software implementation is highly desirable. Experience working with SaaS systems, data integrity programs, and GxP cloud validation strategies. Familiarity and/or industry certification with tools like ARISg database, QMS software platforms such as MasterControl, Veeva Vault QualityDocs/Quality Suite/Safety, paperless validation tools (Kneat, ValGenesis, or similar). Experience of working for US/EU based clients is a plus Show more Show less

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 directly impact customer satisfaction, retention, and the overall success of zipp.ai. Cutting-Edge Technology: Work at the intersection of AI and the critical Life Sciences compliance domain. Growth & Mentorship: Collaborate directly with an experienced founding team in a fast-paced learning environment. Competitive Compensation: We offer a competitive salary and the potential for equity (ESOPs) as a core team member. Role Description As our SaaS Implementation Consultant, you will be the bridge between our innovative AI platform and our clients' complex GxP environments. You will be responsible for the entire post-sale customer journey, from initial discovery and solution design to configuration, training, and ongoing support. Your work will be critical to ensuring customer success, driving adoption, and building the foundation for long-term partnerships. Key Responsibilities Needs Assessment: Lead discovery workshops with clients to deeply understand their specific GxP processes, quality systems, document hierarchies, and compliance requirements to ensure our solution is tailored to their needs. Solution Design: Plan and architect the end-to-end implementation strategy, including defining configuration specifications, mapping data flows, and planning integrations with existing client systems (e.g., QMS, DMS). Configuration and Testing: Configure our AI platform according to the solution design, including setting up user roles, workflows, and initial rule sets. You will also manage and support User Acceptance Testing (UAT) with the client. Training and Onboarding: Develop and deliver comprehensive training materials and sessions for various user groups, from SMEs and QA to general users, guiding them through a smooth onboarding process. Issue Resolution: Act as the primary technical point of contact for clients during implementation, expertly troubleshooting and resolving any functional or technical issues that arise. Project Management: Manage the implementation project lifecycle from kickoff to go-live, creating project plans, tracking progress against milestones, managing scope, and ensuring deadlines are met. Customer Support & Success: Provide post-go-live support to ensure clients are successfully using the platform, while gathering feedback to share with the product and engineering teams for continuous improvement. Skills & Qualifications We Require Proven experience in a client-facing role, such as SaaS implementation, technical consulting, or solutions architecture. Technical Skills: Solid understanding of SaaS architecture, cloud technologies (e.g., Azure), API integrations, and software development lifecycles. Communication Skills: Exceptional verbal and written communication skills, with the ability to explain complex technical concepts to both technical and non-technical stakeholders. Problem-Solving Skills: A strong analytical and systematic approach to identifying, troubleshooting, and resolving complex issues. Project Management Skills: Demonstrated ability to manage projects, prioritize tasks, manage timelines, and communicate status effectively. Business Acumen: A good understanding of general business processes and the ability to connect technology solutions to tangible business value like efficiency and productivity. What Will Make You Stand Out (Preferred Skills) Experience in the Pharmaceutical, Food, or Medical Device industries. Strong knowledge of GxP regulations (GMP, GCP, etc.) and quality management principles. Quality Assurance professional, or experience with Quality Assurance projects 1-2 years of consulting experience Experience with common Life Sciences systems (e.g., Veeva Vault, MasterControl, TrackWise, LIMS, MES). Prior experience implementing AI/ML-based SaaS products is a significant plus. If you are driven to build intelligent solutions that have a real-world impact on product quality and safety, we would love to hear from you. How to Apply: Please apply directly via LinkedIn or send your resume and a 20-words write-up on "What makes you different from other candidates?" to hr@zipp-ai.com Show more Show less

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 reports, manuals, etc.) Ensure version control and proper archiving of all documentation. Collaborate with cross-functional teams to obtain necessary approvals and implement document updates. Track and manage documentation workflows using electronic document management systems (EDMS). Prepare regulatory submissions and assist in compiling dossiers for regulatory bodies (e.g., CDSCO, DCGI, USFDA, EMA). Maintain master files for clinical studies and Ethics Committees (EC/IRB). Support internal and external audits by retrieving required documentation promptly. Conduct periodic document reviews and coordinate training record updates for SOP revisions. Maintain confidentiality and data integrity across all records and communication. Qualifications: Pharm-D or PG with Clinical Research Course. Minimum 2-3 years of experience in documentation, preferably in a healthcare, pharmaceutical, or CRO environment. Familiarity with GCP, ICH, and regulatory guidelines. Experience with EDMS (e.g., MasterControl, Veeva Vault) is an advantage. Excellent written and verbal communication skills. Strong attention to detail and organizational abilities. Great in coordination Preferred Skills: Knowledge of regulatory filing formats (e.g., eCTD); SUGAM PORTAL; SAE-Handling; conducting meetings and able to handle multiple clinets on daily basis. able to handle heterogeneric types of research proposals Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook). Ability to manage multiple priorities and meet deadlines. Experience in handling Ethics Committee or regulatory submissions is a plus. Job Types: Full-time, Fresher Pay: ₹18,883.04 - ₹21,319.24 per month Benefits: Health insurance Provident Fund Schedule: Day shift Rotational shift Weekend availability Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person Application Deadline: 30/06/2025

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 collaborating across departments to enhance our regulatory operational Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy, completeness, and adherence to submission standards. Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders. Mentor, train and supervise junior Regulatory Administrators by providing guidance and support. Resolve complex issues related to submission document upload, publishing and system functionality. Contribute to planning and process improvement to enhance regulatory operation. Collaborate with cross functional teams. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 3 years in document management Preferred Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Previous Knowledge compiling and publishing, including eCTD. Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team Proven ability to resolve complex technical issues efficiently. Significant knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

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 authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

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 authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Show more Show less

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 with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

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 submissions, , ensuring compliance with relevant guidelines and regulations. The SRA involves in optimizing processes, mentor team members, and collaborating across departments to enhance our regulatory operational Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Assist under the guidance of Regulatory Manager in auditing and reviewing regulatory submissions for accuracy, completeness, and adherence to submission standards. Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Assist with internal audits and inspections by preparing required regulatory documentation and facilitating communication between stakeholders. Mentor, train and supervise junior Regulatory Administrators by providing guidance and support. Resolve complex issues related to submission document upload, publishing and system functionality. Contribute to planning and process improvement to enhance regulatory operation. Collaborate with cross functional teams. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 3 years in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Advanced knowledge of CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Previous Knowledge compiling and publishing, including eCTD. Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Excellent communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team Proven ability to resolve complex technical issues efficiently. Significant knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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 regulations. Essential functions of the job include but are not limited to: Upload, organize, and maintain regulatory documents within applicable regulatory authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor’s degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years’ experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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 platform. h) Address user inquiries, service requests, and tickets through IT helpdesk systems i) Collaborate with vendors and developers to resolve system bugs and enhance functionalities. Experience: a) Proven experience working with QUMAS or other quality management systems (e.g., MasterControl, Veeva Vault QMS), QUMAS DocCompliance, ProcessCompliance, and Training modules. b) Previous experience in a GxP-compliant environment is highly preferred. c) Experience with document processes, workflows, and standard operating procedures (SOPs) within the QMS platform. d) Experience with generating and analysing reports related to quality management performance, system usage, and compliance status. Skills: a) Strong understanding of document control, regulatory compliance, CAPA, risk management, and workflow automation. b) Experience with SQL databases, Windows/Linux servers, and enterprise system integrations. c) Basic scripting knowledge (PowerShell, Python) is a plus. b) Familiarity with document management systems (DMS) and quality management software. c) Excellent problem-solving skills and ability to troubleshoot technical issues. d) Strong communication and training skills. e) Ability to work both independently and collaboratively with cross-functional teams. Show more Show less

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 authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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 authority submissions portals (e.g. Clinical Trial Information System (CTIS), FDA eGateway, Common European Submissions Platform (CESP), etc.). Coordinate the redaction of confidential and proprietary information in regulatory documents, ensuring compliance with global standards. Liaise with external vendors for document redaction services and track the progress of redaction processes. Assist in preparing, formatting, and completeness checking documents for regulatory submissions (e.g., FDA, EMA, and other global regulatory authorities). Support the creation of regulatory submission packages, ensuring adherence to technical guidelines, as advised by Regulatory Manager Provide publishing and technical support for submission documents, including conversion to compliant formats (e.g., PDF, eCTD). Maintain current knowledge of evolving regulations and communicate updates to the Regulatory Affairs team. Maintain up-to-date tracking logs for submission timelines, regulatory approvals, and document status. Participate in department meetings to stay informed of regulatory updates, project timelines, and submission requirements. Ensure all activities are conducted in compliance with relevant regulatory guidelines and company policies. Qualifications: Minimum Required: Bachelor's degree, or equivalent experience, Computer literacy (MS Office/ Office 365) Fluent in English, both written and verbal. 1-2 years' experience in document management Preferred: Previous experience in clinical research, regulatory affairs, or a related field, particularly within a CRO, pharmaceutical, or biotech company. Familiarity with the CTIS system and experience submitting clinical trial applications under the Clinical Trial Regulation (CTR). Understanding of global regulatory requirements and guidelines, including FDA, EMA, and other regulatory bodies. Experience with document management systems (e.g., eTMF, Veeva Vault, MasterControl) and electronic submission formats (eCTD). Competencies Strong attention to detail and accuracy in handling regulatory documents. Excellent organizational and time management skills, with the ability to prioritize tasks and meet deadlines. Effective communication and interpersonal skills, capable of interacting with internal teams and external stakeholders. Ability to work as part of a team, with a proactive approach to problem-solving. Knowledge of regulatory submission processes and guidelines, including FDA, EMA, ICH, and CTR requirements. Adaptability to work in a fast-paced, evolving regulatory environment Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.