8 Gxp Regulations Jobs

The Digital Risk & Compliance Expert Controls Assurance will be responsible for driving the execution of assessment and testing campaigns such as GxP Periodic Reviews & Third Party Assessments within the Digital Risk & Compliance team. Your impact will extend beyond the team as you support the Digital transformation objective of halving the time from discovery to therapy by ensuring Risk & Compliance at the speed of the business. In this role, you will have the opportunity to work in an international environment as part of a dynamic team, empowered to propose and implement innovative ideas. You will collaborate with diverse business teams and vendors, gaining hands-on experience and contributing to the improvement of controls mitigating Digital risks. Your main responsibilities will include conducting activities related to the execution of GxP Periodic Reviews with a critical thinking mindset, supporting the operational elements of the process, identifying compliance risks, evaluating designed controls, and leading the improvement process. Additionally, you will be involved in supporting the execution of third party quality assessments and audits, identifying compliance risks, evaluating controls, and presenting findings to the Third Party Audit team. The role requires a Bachelor's degree in a scientific, engineering, or Digital/IT discipline, along with 4+ years of experience in Audit/Quality Assurance/inspection in regulated GxP computerized systems environments. You should also have 4+ years of experience in Quality Management, Computerized Systems compliance, or Information Technology contributing to regulated projects, in addition to 2+ years of experience working in the Life Sciences industry. Soft skills such as stakeholder management, adaptability, critical-thinking, problem-solving, leadership, communication, and relationship-building are essential. You should be results-driven, proactive, autonomous, and have a high level of assertiveness. Technical skills required include Audit/Quality Assurance/inspection experience, understanding of relevant life sciences IT risk domains and controls, knowledge of quality management & compliance, industry standards, and IT lifecycle approaches. Fluency in English is mandatory for this position, and you will be expected to demonstrate behaviors like Stretch, putting the interest of the organization first, acting in the interest of patients and customers, and taking action. Skills such as Strategic Thinking, Result Orientation, Relationship, and Influence will also be assessed during the interview process.,

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. Senior Delivery Assurance Associate The Senior Delivery Assurance Associate will serve as a key member of our Delivery Assurance Group, responsible for instantiating delivery assurance with experts who actively partner with delivery teams to bring innovation and ensure consistent adoption of technology delivery best practices across ZS. The role involves working closely with various stakeholders, defining process, enabling process implementation analyzing process compliance ensuing CMMI maturity and compliance, and providing input into the development and maintenance of DAG and risk scores. The candidate will also assist in the management of DAG assets and contribute to various delivery assurance related initiatives and special projects. What You'll Do: Perform periodic project audits / reviews for the project delivery process based on CMMI (Capability Maturity Model Integration) process areas and report non compliances, best practices followed Highlight potential delivery risks and compliance issues for the project milestones Participate in project milestone release readiness review and provide sign offs Assist in QRM cadence planning and work closely with QRM Leads ensuring effective risk management and mitigation throughout lifecycle of projects Conduct trainings on QMS process assets and awareness on best practices Maintain and ensure project process maturity (CMMI Level 3) adherence for ensuring Capability Maturity Model Integration (CMMI) v2.0 Development & Services appraisal and accreditation process Guides and train project teams on Project Management and Delivery Excellence best practices and supporting project management tools such as Atlassian JIRA, Confluence, Microsoft Enterprise Project Management (EPM) & BT Estimation tool As a DAG partner work with project teams to bring in innovation ensure consistent adoption of technology delivery best practices Showcase expertise on Software Quality Management framework such as CMMI Development, CMMI Services and focus on performance and continuous improvement at project as well as organization level Enhance Delivery and Operations maturity through close engagement and planned intervention across all project phases Coaching and training the project team members on focus areas such as Agile project delivery methodology and supporting tool stack Definition and regular enhancement of enterprise level Quality Management System aka Enterprise Delivery Framework (EDF) supporting Development (Waterfall, Agile) as well as Operations projects (Services delivery methodology). Strong understanding of GxP regulations and industry standards. Serve as the point of contact for regulatory agencies and manage audits related to GxP compliance. Experience with software validation tools and methodologies. Develop and maintain policies and procedures that support compliance with GxP,, and other relevant regulatory frameworks. Proficiency in preparing validation documentation. Develop and deliver training programs on GxP compliance, and other regulatory requirements to ensure employees are aware of and adhere to relevant guidelines What You'll Bring: Bachelor's degree in IT or relevant field with a strong academic record. A minimum of 5 years of experience in Delivery Assurance and Quality Management Minimum of 3-5 years of experience in Computer System Validation (CSV) within a GxP-regulated environment (pharmaceutical, biotech, or healthcare preferred). Knowledge and experience in Software Quality Management & Software Quality Standards. Familiarity with regulatory requirements (FDA, EMA, 21 CFR Part 11, GAMP 5, EU Annex 11, etc.). Experience with risk-based validation methodologies. Through understanding and implementation experience of CMMi 2.0 framework for Dev & Services Proficiency in MS Office, including Word, Excel, and PowerPoint. Experience with Project management tools (e.g., Atlassian JIRA, Confluence, MS project ) and Quality Assurance tools CMMi implementation experience (Maturity level 3 at minimum/ High maturity implementation experience preferred ) Familiarity with Pharma compliance and regulations - CFR Part 11/GXP Strong communication skills, both written and verbal, for reporting and interacting with stakeholders. Ability to work independently and as part of a team Willingness to adapt to evolving industry standards and technologies Ability to manage a wide variety of tasks and meet deadlines, and reliability/dependability Proven ability to work creatively and analytically in a problem-solving environment Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At:

The MES Lifecycle Manager role at Sanofi is integral to the company's digital transformation and standardization efforts within Manufacturing & Supply. You will be responsible for overseeing the lifecycle management of MES systems, including MARS implementations across multiple production sites globally. Your main focus will be on strategic planning and execution of MES installations, updates, and migrations to optimize performance, reduce obsolescence, and align capabilities with digital transformation goals. Your key responsibilities will include developing and executing a comprehensive MES lifecycle planning strategy, orchestrating high-level planning of MES initiatives across industrial sites, and establishing collaboration with manufacturing sites for successful implementation. You will also drive multiple concurrent MES lifecycle initiatives, oversee projects, and ensure alignment with stakeholders and objectives. As the MES Lifecycle Manager, you will drive the evolution of MES capabilities by leveraging emerging technologies such as AI, Cloud services, and DevOps. You will also lead change management efforts, guide risk management and compliance strategies, and collaborate with various stakeholders to support MES lifecycle initiatives. To be successful in this role, you should have a Master's degree in engineering, Computer Science, or a related field, along with 12+ years of experience in pharmaceutical manufacturing systems. Strong leadership, project management, and communication skills are essential, as well as a deep understanding of MES technologies, GxP regulations, and manufacturing processes. You should also possess strategic thinking abilities, interpersonal skills, and the ability to influence and align diverse groups across the organization. Fluency in English is required, and additional languages are a plus. The working environment is global and matrix-based, with occasional travel to manufacturing sites in Europe, North America, and Asia. Join Sanofi and be part of a team dedicated to pursuing progress and discovering extraordinary advancements in science. Together, we can make miracles happen and improve people's lives through innovative solutions and transformative work. Let's Pursue Progress and Discover Extraordinary together.,

You should have a minimum of 5+ years of ETL testing experience with expertise in ETL test planning, functional testing, performance testing, developer management, and defect management using Application Lifecycle Management (ALM) tools. Your experience should include ETL testing with tools such as Informatica, SSIS, Power BI, and Snowflake. Additionally, you should have proficiency in test data management, processes analysis, and documentation using industry standard tools. It is essential to have experience working with scrum/agile or other project management methodologies. Knowledge or experience in the life sciences/biotech space is preferred. Strong written and verbal communication skills are required for this role. Experience in testing or leading testing for ETL is preferred, and experience with other account management systems is a strong plus. Knowledge of Gxp regulations, Python Scripting, and Automation testing would be beneficial. The work locations available for this position are Chennai, Bangalore, Coimbatore, and Pune. The work hours are from 2 pm to 11 pm, and the work mode is hybrid.,

You will be responsible for overseeing and coordinating the Quality Assurance (QA) program to support customer accounts, operational teams, audit and inspection programs, and the quality management system (QMS) for the Digital Products and Solutions (DP&S) organization. Your role will involve providing guidance, interpretation, support, and training to delivery and development groups on regulations, guidelines, corporate standards, and policies. You will also be involved in documentation, reporting, investigation, and closure of compliance issues such as deviations, quality issues, CAPAs, and audit findings. Additionally, you will organize and deliver training to other departments on Quality services, quality initiatives, and regulatory compliance. It will be your responsibility to evaluate policies, procedures, and system requirements for compliance with regulations and provide recommendations for continuous process improvements. You will serve as an author and/or independent reviewer of Quality Assurance Standard Operating Procedures (SOPs) and advise Quality Assurance leadership on the governance of DP&S offerings from a QA and regulatory compliance perspective. Your role will also involve maintaining the Quality Assurance database, hosting customer audits, mock regulatory inspections, and regulatory facility inspections as needed. To qualify for this position, you should have a Bachelor's Degree and at least 7 years of Quality Assurance experience in pharmaceutical, technical, or related areas. You should have extensive knowledge of pharmaceutical research and development processes, SDLC, regulatory environments, and current GXP regulations and guidelines. Strong interpersonal skills, problem-solving abilities, risk analysis, negotiation skills, and exceptional training capabilities are essential for this role. Effective organization, communication, team orientation, and leadership skills are required, along with the ability to work independently, manage multiple projects successfully, and establish effective working relationships with coworkers, managers, and clients. Your role will play a crucial part in ensuring compliance, quality, and continuous improvement initiatives within the DP&S organization.,

In this vital role, you will facilitate Scrum events and processes for the Regulatory Structured Submissions Team. Your responsibilities include enhancing team communication and collaboration, ensuring alignment with program goals, managing risks and dependencies, and driving continuous improvement. The Scrum Master adapts and refines SAFe principles to suit organizational needs, standardizing and documenting practices. Lead and handle product delivery using agile frameworks and techniques, aligning with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs. Collaborate with business partners, Architects and Engineering teams to prioritize release scopes and refine the Product backlog. Lead and facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and partners understand how they fit into the product backlog. Ensure Acceptance Criteria and Definition of Done are well-defined. Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Stay focused on software development to ensure it meets requirements, providing proactive feedback to partners. Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements. Identify and manage risks associated with the systems, requirement validation, and user acceptance. Develop & maintain documentations of configurations, processes, changes, communication plans and training plans for end users. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement. We expect you to have a Doctorate degree / Master's degree / Bachelor's degree and 8 to 13 years Computer Science, IT or related field. Preferred qualifications include 6-8 years of experience working in the global pharmaceutical industry, solid understanding of GxP regulations, proven experience as a Scrum Master, expertise in Scaled Agile framework practices and principles, excellent communication and interpersonal skills, and experience with Agile project management tools. This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.,

As an experienced professional with over 3 years of experience in Computer System Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, or medical devices, you will be responsible for developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. Conducting risk assessments and gap analyses will be a key part of your role to identify potential quality issues and implement necessary corrective actions. Your responsibilities will also include developing and maintaining quality documentation, such as Standard Operating Procedures (SOPs), validation plans, test cases, and reports. You will actively participate in the selection, implementation, and qualification of new IT systems and software, while providing training and guidance to users on CSV and IT quality best practices. Collaboration with cross-functional teams, including IT, engineering, and manufacturing, will be essential to ensure compliance with regulatory requirements. Staying informed about industry best practices and regulatory changes related to CSV and IT quality will be crucial in this role. Additionally, you will be involved in performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this position, you should hold a Bachelor's degree in a related field and possess a deep understanding of GxP regulations, such as 21 CFR Part 11 and Annex 11, along with industry best practices for CSV. Experience with software development lifecycle (SDLC) methodologies and quality management systems (QMS) is required. Excellent written and verbal communication skills are essential, as you will be expected to effectively communicate technical information to both technical and non-technical audiences. Strong analytical and problem-solving skills are also important for this role. The ability to work independently as well as part of a team is necessary to excel in this position. If you meet these qualifications and are interested in this opportunity, please share your updated resume with ruchita.parsekar@e-stonetech.com.,

As an experienced professional with over 3 years of experience in Computer Systems Validation (CSV) and IT quality assurance within regulated industries such as pharmaceuticals, biotechnology, and medical devices, you will be responsible for the following key tasks: - Developing, executing, and documenting CSV protocols and reports for both new and existing computer systems and software applications. - Conducting risk assessments and gap analyses to identify potential quality issues and implementing corrective actions as necessary. - Developing and maintaining quality documentation including Standard Operating Procedures (SOPs), validation plans, test cases, and reports. - Participating in the selection, implementation, and qualification of new IT systems and software. - Providing training and guidance to users on CSV and IT quality best practices. - Collaborating with cross-functional teams (e.g., IT, engineering, manufacturing) to ensure compliance with regulatory requirements. - Staying updated on industry best practices and regulatory changes related to CSV and IT quality. - Performing internal audits and supporting external audits related to CSV and IT quality. To be successful in this role, you should possess the following qualifications: - A Bachelor's degree in a related field. - 3-4 years of experience in CSV and IT quality assurance within regulated industries. - Strong understanding of GxP regulations such as 21 CFR Part 11, Annex 11, and industry best practices for CSV. - Experience with Software Development Lifecycle (SDLC) methodologies and Quality Management Systems (QMS). - Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences. - Strong analytical and problem-solving skills. - Ability to work both independently and as part of a team. If you meet the qualifications and are looking for a challenging opportunity to further develop your skills in CSV and IT quality assurance, we encourage you to share your updated resume with us at ruchita.parsekar@e-stonetech.com.,