6 Vmp Jobs

Roles & Responsibilities: Collaborates with internal teams, including IS functions (Infrastructure, ITIL process owners), external service providers, Corporate Quality, and Medinfo business units. Leads and develops test plans, test cases, test scripts and test reports on multiple projects and ultimately validates that expectations of our users are met during the testing process Responsible for defect tracking, investigation, and resolution throughout testing and validation phases. Prepare, review, and approve test cases to validate system functionality and performance against business requirements. Review and execute Test Runs in alignment with pre-approved testing protocols and documentation best practices. Create, review, and maintain the Requirements Traceability Matrix (RTM) to ensure full test coverage and validation compliance. Lead the creation and review of Validation Summary Reports (VSRs), capturing outcomes, deviations, and traceability to requirements. Draft and manage OQ Pre/Post-Approval Protocols, including alignment with qualification strategy and risk assessments. Collaborate closely with the Amgen Quality Assurance team to ensure validation artifacts meet regulatory and audit-readiness criteria. Drive Change Request (CR) and Change Control processes, from initiation through approval, ensuring accurate system impact assessment and documentation. Initiate and manage ISM Change Requests for release planning and versioning coordination. Serve as the primary liaison for internal and external stakeholders, ensuring cross-functional alignment during validation lifecycle activities. Ensure timely documentation reviews and approvals in accordance with Amgens standard operating procedures and regulatory requirements. Maintain and enforce validation lifecycle documentation, including Test Plans, Protocols (IQ/OQ/PQ), Design Specifications, and Summary Reports. Drives advancements of automated testing, based on ongoing analysis of manual testing efforts versus efforts to keep test automation current Support system go-lives, data migrations, and infrastructure changes with appropriate validation oversight. Contribute to the continuous improvement of validation templates, SOPs, and risk-based testing strategies. Provide mentorship on compliance issues related to computerized systems, validation best practices and documentation quality and ensure continuous improvement of validation processes. Support regulatory audits and inspections, providing documentation and expert insights as needed. Demonstrate leadership in the end-to-end validation activities for complex IT GxP projects and to operate in alignment with CSV regulations; ITIL Change and Problem Management. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree and 3 to 4 years of Computer Science, IT or related field experience OR Bachelors degree and 5 to 6 years of Computer Science, IT or related field experience OR Diploma and 9 to 10 years of Computer Science, IT or related field experience Preferred Qualifications: Demonstrated leadership in GxP validation for complex IT systems and enterprise platforms. Proven experience in validating GxP-critical systems per 21 CFR Part 11, Annex 11, and data integrity standards Proven experience in creating and managing validation artifacts including Validation Plans (VMP) Test Plans, IQ/OQ/PQ Protocols, RTMs, and VSRs. Strong working knowledge of change control systems, including CR and CCMS processes. Proficiency in Quality Management Systems (QMS), including electronic documentation and workflow tools. Experience using ServiceNow, HP ALM, or similar platforms for defect tracking and testing. Effective collaboration with Quality, Regulatory, and IT functions in a regulated industry environment. Deep understanding of SDLC and CSA principles. Experience supporting regulatory inspections and audits. Knowledge of Agile and SAFe methodologies in a validation context. Pharmaceutical industry experience is a strong plus. Must-Have Skills: Proficient in using enterprise tools such as ServiceNow, HP ALM for managing defect tracking, test execution, and validation workflows, ensuring traceability, accountability, and audit-ready documentation throughout the project lifecycle Ability to manage complex change processes, including initiating, reviewing, and approving change requests and attending Change Approval Board meetings. Skilled in partnering with internal IT, Quality Assurance, external vendors, and business units to align validation deliverables with evolving regulatory expectations and business priorities. Proficient in leading test plans, test scripts, reports, requirements traceability, and execution of IQ/OQ/PQ protocols within regulated GxP and CSV-compliant computer systems, ensuring adherence to validation, audit, and documentation standards Good-to-Have Skills: Experience with stakeholder management, ensuring seamless coordination across teams and driving the successful delivery of technical projects Experience supporting regulatory audits and inspections, with the ability to provide validation documentation and subject matter expertise Experience enhancing validation SOPs, templates, and documentation tools for continuous improvement Ability to lead and facilitate cross-functional validation activities with geographically dispersed teams Exposure to testing integrations with platforms like Salesforce, AWS, MuleSoft, or other enterprise systems Experience supporting regulatory inspections and audits, with the ability to present validation documentation and processes confidently. Familiarity with Agile and SAFe frameworks, with the ability to integrate validation practices into iterative development cycles. Professional Certifications Certified Computer System Validation Professional (CSV) SAFe for Teams or SAFe Scrum Master (preferred) ISTQB or equivalent software testing certification Soft Skills: Excellent leadership, coaching, and mentoring capabilities. Strong analytical, problem-solving, and critical-thinking skills. Outstanding communication and stakeholder management abilities. Proactive and self-motivated with a keen eye for detail. Ability to manage multiple projects and competing priorities in a fast-paced environment. A collaborative spirit with a passion for quality and compliance excellence. Experience in working with Quality Assurance (QA) and Regulatory/Compliance teams for audits and inspections

Purpose of the Manager Quality & Job Role: Aakash is looking for an experienced Manager Quality (Training & Development) who shall be responsible for monitoring, evaluating, and improving the quality of customer interactions in all branches Pan India (Telephonic & F2F). Role is very dynamic in nature and shall need an experienced and self-motivated professional who shall take full responsibility of individually assigned projects as well as team handling. This role involves analyzing performance data, coaching agents, and implementing strategies to enhance the overall customer experience. The Call Quality Manager would closely work with team leaders, trainers, and other business stakeholders to ensure that quality standards are consistently met. As Quality Manager, you are expected to: 1. Work closely and communicate effectively with CXOs, Senior Business leaders, Regional Training team to identify/ assess training priorities on an ongoing basis and proactively develop solutions to drive business. 2. Ensures team monitors and evaluate inbound and outbound calls, chat, and email interactions for compliance with company standards and quality metrics followed by regular feedback emails to branch stakeholders. 3. Conduct and analyze TNA (Training Needs Analysis) for Quality Assurance team and provide quarterly/annual training plan to develop QA skills. 4. Offer feedback to branches on how to improve specific aspects of their interactions that directly impact CSAT Score of branches. 5. Study NPS (Net Promoter Score) Data and take effective measures to drive process improvements and training initiatives. 6. Prepare VMP (Voice monitoring plan) and ensure target is met followed by validation of good and fatal calls and regularly ensuring Call Calibration followed by publishing regular quality reports to senior management. 7. Analyze call quality data to identify trends, patterns, and areas for improvement. Use RAG analysis to forecast potential issues and proactively address them before they impact overall quality. 8. Work with cross-functional teams to develop and implement process improvements that enhance call quality. 9. Lead initiatives to improve customer satisfaction scores and reduce escalations. 10. Lead the team and ensure effective team management skills and team development To be successful in the Quality Manager Role you are required to have: 1. Strong communication & Excellent written and verbal communication skills. 2. Excellent organizational skills and ability to multitask with strong business acumen. 3. Excellent time and work management skills, ability to prioritize, ability to handle team dynamics, attention to detail and ability to meet established deadlines. 4. Strong project management skills. 5. Ability of stakeholder & vendor management. 6. Certification in Quality Management (e.g., Six Sigma, etc) would be an added advantage. Must to have Attitude: 1. Dynamic professional with excellent interpersonal skills and has enterprising style of work. 2. Desired Traits: Self-starter, proactive, quick & adaptive. 3. Emotional intelligence to work and lead the team. Qualification: Post-Graduate in any discipline (Preferably full time MBA) Experience: 1. 10 to 12 years of experience into Quality & Training. 2. 5+ Years of experience in team management.

Role & responsibilities To prepare and review Validation Master Plan (VMP, PVMP, CVMP, QMP). To follow the validation master plan. To prepare and review Qualification and Validation Documents and execution as per protocol. To update equipment and utility periodic requalification / re-verification schedules on monthly basis or whenever required. Handling and storage of all quality document like BMR, BPR, log book, Protocol, Report and SOP throughout life cycle. Preparation and review of URS, FS, DS, DQ, RA, IQ, OQ & PQ and summary reports for Equipment, System and Utilities. Monitoring of PPQ and cleaning validation activities.

collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.

Job Description Overview: We are looking for a meticulous Computer System Validation Assistant Manager to champion the integrity of our computerized systems at Evertogen Life Sciences. In this pivotal role, you will be instrumental in ensuring our systems meet stringent GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11. Your expertise will drive the development and execution of validation plans, risk assessments, and comprehensive validation documentation across manufacturing, quality control, and utilities. Collaborating closely with cross-functional teams such as QA, IT, and manufacturing, you will oversee system qualification, manage change controls, and ensure data integrity. As a guardian of compliance, you'll prepare for audits, conduct periodic reviews, and foster continuous improvement in our CSV activities. If you're passionate about maintaining the highest standards of data integrity and regulatory adherence within a dynamic pharmaceutical environment, seize this opportunity to make a significant impact on our global operations and contribute to the delivery of safe and effective medicines. Job Details: Industry: Pharmaceutical Department: Quality Assurance / IT Role: Computer System Validation Assistant Manager Location: Hyderabad Compensation: 6-8LPA Experience: 4-6 years Qualification: Bachelor's or Master's degree in Computer Science, Information Technology, or related field Responsibilities: CSV Planning and Implementation Develop and execute comprehensive Computer System Validation (CSV) plans in compliance with GxP regulations for software used in manufacturing, QC, and utilities. Conduct thorough risk assessments and impact analysis for computerized systems used in the manufacturing, quality control, and utilities of oral solid dosage (OSD) products. Maintain an updated IT inventory of computerized systems and meticulously review validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Master Plans (VMP). Create and maintain validation protocols (IQ, OQ, PQ) to ensure systems meet predetermined acceptance criteria. Collaborate with cross-functional teams to align validation activities with project timelines and business objectives. Regulatory Compliance Ensure all computerized systems comply with applicable regulatory guidelines, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Prepare for and actively participate in internal and external audits, providing evidence of system compliance and validation. Implement and monitor robust measures to ensure data integrity across all computerized systems, adhering to ALCOA principles. Stay abreast of current regulatory requirements and industry best practices related to CSV and data integrity. Develop and maintain standard operating procedures (SOPs) related to computer system validation. System Qualification and Maintenance Oversee the qualification of new systems, including laboratory instruments, production equipment, and software applications, using a lifecycle management approach. Conduct periodic reviews of validated systems to ensure ongoing compliance, functionality, and performance. Manage change controls for updates or modifications to validated systems, ensuring appropriate re-validation activities are performed. Troubleshoot and resolve issues related to computerized systems during validation and routine use. Ensure proper documentation and tracking of system changes and maintenance activities. Collaboration and Coordination Foster strong cross-functional coordination with QA, IT, OEM, manufacturing, and other departments to ensure seamless validation and compliance of computerized systems. Manage relationships with vendors to ensure software and hardware systems meet validation and compliance requirements. Provide training and mentorship to team members and end-users on CSV processes and compliance requirements. Act as a subject matter expert (SME) for CSV-related inquiries and provide guidance to stakeholders. Participate in project meetings and provide updates on validation progress and potential risks. Risk Management Perform comprehensive risk assessments to identify critical system elements and prioritize validation activities. Proactively identify and resolve issues related to computerized systems during validation and routine use. Identify opportunities for process improvement in CSV activities and implement solutions to enhance efficiency and effectiveness. Conduct gap assessments for existing systems to identify compliance gaps and develop remediation plans. Maintain a risk register to track identified risks and mitigation strategies. Documentation and Reporting Ensure timely and accurate documentation of all validation activities and maintain comprehensive validation status records. Prepare detailed validation reports and summaries for management review and regulatory submissions. Analyze trends in system performance and validation data to proactively address potential risks and improve system reliability. Maintain a library of validation documentation, including protocols, reports, and SOPs. Generate metrics and key performance indicators (KPIs) to track the effectiveness of CSV activities. General Expectations and Past Experiences: Possess a strong understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11, and their application to computerized systems. Demonstrate proven experience in Computer System Validation (CSV) within the pharmaceutical industry, specifically related to OSD manufacturing. Exhibit proficiency in validating computerized systems used in OSD manufacturing, including laboratory systems (e.g., HPLC software), ERP systems, and production equipment software. Showcase experience with GAMP 5 guidelines and risk-based validation approaches. Proficient in creating and reviewing validation documentation, including URS, FRS, VMP, and validation protocols (IQ/OQ/PQ). Exhibit strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues related to computerized systems. Demonstrate effective communication and team coordination abilities, with experience collaborating with cross-functional teams.

To prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and CSVMP). To follow the validation master plan.To prepare and review qualification and validation documents and execution as per protocol. Required Candidate profile Preparation&review of URS,FS,DS,DQ,RA,IQ, OQ&PQ & summary reports for Equipment, System&Utilities.Handling & storage of all quality document like BMR,BPR,log book, protocol & SOP throughout life cycle