3 Gxp Regulations Jobs

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.,