3 Vmp Jobs

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

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.