70 Gamp Jobs - Page 2

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Lets find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

SAP FI - Treasury Risk and Cash Liquidity Mgmt - Expert proficiency in SAP FI Treasury - Ability to read through the customer business processes and simultaneously formulating the adoption of the best business practices in meeting the foreseeable challenges Ability to review, validate the right set of questions Create solution workshops with senior business managers, review validate solutionproposals and estimates, rendering advice on best business practices and getting the buy in to adopt these practices Ability to create solution road maps integrating multiple disparate processes Ability to present and get the buy in forthe solution from senior managers Implement the solution by leading the team In addition to leveraging the standard processes, come out with innovative solutions and timely execution of the project within the agreed time lines Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills Mandatory Skills: SAP FS-CM Functional. Experience5-8 Years.

SkillSAP FI-FSCD LocationPune and Bangalore Minimum of 4 years SAP experience Configure G/L, A/P, A/R, Asset Accounting, Interface Integrations, Experience on Collections and Disbursements (FS-CD) Experience providing application support Relevant SAP certifications are a plus Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of clients network/ server/ system/ storage/ platform/ infrastructure and other equipments to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the defined resolution timeframe Perform root cause analysis of the tickets raised and create an action plan to resolve the problem to ensure right client satisfaction Provide an acceptance and immediate resolution to the high priority tickets/ service Installing and configuring software/ hardware requirements based on service requests 100% adherence to timeliness as per the priority of each issue, to manage client expectations and ensure zero escalations Provide application/ user access as per client requirements and requests to ensure timely solutioning Track all the tickets from acceptance to resolution stage as per the resolution time defined by the customer Maintain timely backup of important data/ logs and management resources to ensure the solution is of acceptable quality to maintain client satisfaction Coordinate with on-site team for complex problem resolution and ensure timely client servicing Review the log which Chat BOTS gather and ensure all the service requests/ issues are resolved in a timely manner Deliver NoPerformance ParameterMeasure1.100% adherence to SLA/ timelines Multiple cases of red time Zero customer escalation Client appreciation emails Mandatory Skills: SAP FI Financial Supply Chain Management. Experience3-5 Years.

Candidate must have hands on experience in Werum PAS-X/FTPS/Syncade/Opcenter development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements. Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills. Interested Candidates can send their cv's to frichardson@allegisglobalsolutions.com Looking for candidates from Pharma Companies. Regards, Franklin.A

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams Take your career farther than you thought possible, Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more careers bms,/working-with-us , Position Summary Supports the execution of Computer Systems Validation (CSV) activities for systems and applications in Pharma GxP space under the guidance of Validation Lead/ Manager Collaborate with peers across BMS on CSV activities, At BMS, digital innovation and Information Technology are central to our vision of transforming patients' lives through science To accelerate our ability to serve patients around the world, we must unleash the power of technology " We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care " " If you want an exciting and rewarding career that is meaningful, consider joining our diverse team! Key Responsibilities Functional and Technical Support execution of CSV activities for applications across multiple GxP business areas to ensure 'fit for use' before release to production environment Support execution of Qualification activities as it relates to infrastructure applications and hardware in a timely manner Support validation lead in conducting risk & impact assessment to determine the extent of validation and qualification Author CSV deliverables including but not limited to Plans & Summary Reports Support the SDLC process as it relates to application validation and infrastructure qualification Review and approve change tickets for applications and ensure alignment with change management process, Conducts periodic reviews of applications to ensure applications remain in a state of compliance, Provides regular status updates to one up manager and escalates any potential issues in a timely manner Qualifications & Experience Minimum Bachelor's degree and 1-4 years of experience in IT Quality, Computer System Validation and Testing, Experience supporting validation of one or more GxP systems, Experience in change management process General knowledge (desirable) of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools , Familiarity with test automation tools desirable Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies Works predominately within established procedures Ability to work under minimal supervision Demonstrates openness to learning and developing Takes a responsibility for their own development and growth Good English verbal and written communication skills including the ability to write clear and precise documentation If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career, Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues, On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function, BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer

We are seeking a highly skilled and motivated Senior Analyst - Service Delivery Manager to oversee the services of our research applications and all associated service delivery activities in the Healthcare sector. In this role, you will foster a deep level of communication with the business teams to ensure effective solutions and high customer satisfaction. Have Outstanding verbal and written communication skills, along with the ability to understand service requests and incidents in healthcare, are key success factors. Manage end-to-end service delivery for resource applications, ensuring alignment with client expectations and business goals. Collaborate with cross-functional teams, including internal technical teams and external vendors, to facilitate smooth ticket execution. Develop and maintain strong relationships with clients, acting as the primary point of contact for service-related inquiries. Monitor ticket progress, identify risks, and implement mitigation strategies to ensure timely delivery, while also being willing to work on tickets for complex applications. Conduct regular reviews with clients to assess satisfaction and identify opportunities for improvement. Provide leadership and guidance to project teams, ensuring adherence to best practices and GxP and Non-GxP standards. Serve as a technical expert and technical lead for projects, providing insights and direction on technical matters. Display a sense of urgency in completion of key responsibilities. Who you are: Bachelors or masters degree in a relevant field. 5+ years of experience in Service delivery, project management, or related roles, preferably in the Health care, Life science or technology sectors. Strong understanding of GxP regulations and compliance in the healthcare or life science industry. Proven ability to manage complex requests and drive results in a fast-paced environment. Experience in Change and Release Management, along with incident and problem management. Proven experience in leading technical teams and projects supported with external consultants and be comfortable in working with both business- and technical teams. Experienced in service delivery framework and ensuring compliance to SLA and KPIs.

Role & responsibilities To lead and manage the Computer System Validation (CSV) activities for our injectable manufacturing operations. The candidate need to ensure compliance with regulatory requirements (e.g., US FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and internal quality standards for all GxP-relevant computerized systems used across production, quality control, and laboratory environments. Lead and oversee all CSV activities for GxP-critical systems (LIMS, ERP, MES, SCADA, PLCs, EMS, BMS, etc.) in the injectable manufacturing setup. Develop and maintain validation master plans (VMPs), risk assessments, validation protocols (IQ/OQ/PQ), and reports in line with regulatory expectations and industry best practices. Ensure validation lifecycle management, including periodic review, re-validation, and change control assessments. Collaborate with IT, Quality, Engineering, Production, and external vendors to ensure smooth implementation and validation of new computerized systems or upgrades. Drive data integrity initiatives and compliance across computerized systems and related workflows. Conduct internal audits, gap assessments, and readiness checks for regulatory inspections related to CSV. Provide training and guidance to cross-functional teams on CSV policies, procedures, and regulatory updates. Track regulatory developments and industry trends to continuously improve CSV and data integrity frameworks Preferred candidate profile B.E./B.Tech or a Masters in Pharmacy with 12 - 16 years of experience in Computer System Validation within regulated pharmaceutical manufacturing, preferably injectable / sterile dosage forms. Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Hands-on experience with LIMS, ERP, SCADA, BMS/EMS, and electronic batch records. Experience in handling regulatory inspections (e.g., USFDA, MHRA, EU, WHO) from a CSV perspective

Roles and Responsibilities : Develop and maintain GXP (Good X Practices) documentation for pharmaceutical processes, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to identify areas for improvement in CSV (Commercial Specifications) and implement changes as needed. Conduct audits of manufacturing facilities to ensure adherence to cGMP guidelines, identifying non-conformities and implementing corrective actions. Provide training on GAMP (Good Automated Manufacturing Practice) principles to production staff. Job Requirements : 1.5-5 years of experience in a pharmaceutical or life sciences industry setting. Strong understanding of GXP, CSV, gGMP, and GAMP principles. Ability to work effectively in a fast-paced environment with multiple priorities.

Role & responsibilities Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written) Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Preferred candidate profile from pharma Company ro worked for pharma on 3rd party for atleast 3 yrs Contact Interested candidates can share there updated cv at ankita@topgearconsulatnts.com

Department Commissioning and Qualification (USP / DSP / Clean utilities) How you might spend your days (Main Roles & Responsibilities) As Senior Engineer C&Q, youll be working with highly skilled SeniorEngineers and Engineers and still growing across Denmark and Indian teamswhere youll: Would like to help making complex biopharma facilities more sustainable. Driving the project with Science and Risk based Validation (SRV) concept. Work very closely with our customers Have high knowledge of process equipments systems Should have knowledge on terminologies of symbols used in PID. Execute C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendors, and QA) of the project organization Align quality and validation concept with customers quality system & validation concept Define scope of C&Q activities in project and scope of work within quality work package incl. relevant C&Q activities Ensure changes to scope are brought to the attention of Project Management. Generate validation deliverables like IQ, OQ, PQ protocols and reports, etc. Act as Smarter Execution consultant for Project Members. Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500). Conduct follow-up on QAP planned C&Q activities Who you are (Preferred Competencies) We care about who you are as a person. In the end, how you work, and yourenergy is what impacts the effort we do as a team. As a Biotech person,you: Thrives in a fast-paced environment with many concurrent tasks. Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns. Hands on experience in planning / directing C&Q activities of process equipments (upstream and downstream and clean utilities) in DS facility qualification Should have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc. Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures. The miles youve walked (Education and WorkExperience) In all positions there are some things that are needed, and others a bonus. Webelieve these qualifications are needed for you to do well in this role: Bachelors or masters degree in a relevant science, engineering, or pharmaceutical field. 10-15 years' experience performing commissioning and / or qualification activities in an FDA regulated industry. Have hands on experience in validation deliverables like URS, design review, P&IDs, FAT, SAT, IQ, OQ, PQs, protocols, and reports generation & execution, etc. Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities : Technology Support Under supervision, conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to new study set-up - Periodic report configuration and generation with oracle Analytics. Ad-hoc report configuration and generation with oracle Analytics. Expedited report rule configuration with oracle Analytics. End-user support. Provide support in the planning and delivery of the handover of the safety database from client to Parexel were contracted to take over the pharmacovigilance tasks for client projects. Provide support in the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted. Adhere to standard operating procedures and controlled documents that pertain to safety technology. Organizational Representation Interface with other Parexel groups (such as TQM, QA, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed. Support colleagues when working with external auditors and inspectors during the examination of safety technology. Issue Management Under supervision, collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems. Team Support Provide support to new staff in the systems and activities necessary for the fulfillment of their job responsibilities. Change Management Under supervision, support change management in accordance with the Software Development Life Cycle. Under supervision, support execution of tasks for software updates, change requests and application support for the supported applications. Under supervision, support the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvement. Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards. Skills: Good interpersonal, verbal, and written communication skills. Client focused approach to work. Good analytical and problem-solving skills. Good organizational and customer service skills. Willingness to work in a matrix environment and to value the importance of teamwork. Provide support to a team working through problem management. Under supervision, take ownership of core tasks related to the support and maintenance of safety technologies. Basic System Administration and application support skills within pharmacovigilance. safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection. Basic skills in using standard scripting languages e.g., SQL. Knowledge of industry standard Service Desk Tools. Basic technical writing capability. Knowledge of standard SDLC processes including change management. Knowledge of Agile methodology. A flexible attitude with respect to work assignments and new learning. Under supervision, complete multiple and varied tasks with enthusiasm and prioritize workload. Knowledge of system validation and change management. Basic knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP. Basic knowledge of Pharmacovigilance roles, standards and practices. Basic knowledge of GVP and GCP. Education: Bachelor’s degree in engineering/computer science, master's or equivalent preferred.

Computer System Validation Analyst Experience: 3-6 years Location: Hyderabad(On-Site) Roles and Responsibilities: Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, EU Annex 11) Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents Conduct impact assessments, risk assessments, and manage change control processes Handle CAPA, incident management, and release management activities related to Validation activities Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS Utilise JIRA for tracking tasks, issues, and project progress Collaborate with cross-functional teams to ensure successful Validation Documents preparation Stay up-to-date with industry best practices and regulatory changes related to Validation Qualifications: 3+ years of proven experience in serialisation implementation within the pharmaceutical industry Strong understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9) Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM) Familiarity with quality management systems (QMS) and SOP development Proficiency in using JIRA or similar project management tools Excellent communication and interpersonal skills Preferred Skills: Experience with specific serialisation software and hardware solutions (mention specific platforms if applicable) Knowledge of supply chain management principles Certification in relevant areas (e g-, quality management, project management) Show more Show less

Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook and PI Vision Hands on experience in implementing, configuring and troubleshooting of OSI PI Interfaces including, but not limited to, OPC DA, PItoPI, RDBMS and UFL and has successfully implemented within several client projects. Good understanding of standards & protocols like ISA S88, ISA S95, OPC etc. Excellent working knowledge of OSI PI systems, including functional and technical features as well as limitations of OSI PI Product suite Responsibilities : IT-OT integrations including Industrial Connectors such as Kepware. Mentors System Analysts and can provide UAT & Validation support. Ability to work with all levels of the organization, both technical and non-technical. Good knowledge in Computerized System Validation, GAMP, GxP environments, Quality Systems. PI Data Access Methodologies AF SDK, OLEDB/ODBC/JDBC Provider, PI OPC DA/HDA Server, PI Web API Willingness to learn special and new technologies (Edge technologies and IoT). Experience and desire to work in a Global delivery environment. Level 100 & Level 200 Accredited preferred

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Validation Lead Role Name Validation Lead Department Name Enterprise Engineering and Analytics (EEA) Role GCF 4 Job Family Software Development Engineer-Test I I Hiring Manager Name Asha Rani ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines . Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant . Roles & Responsibilities Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and platform teams to drive validation activities and meet project deadlines. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor’s /Masters degree in computer science and engineering preferred, other Engineering field is considered Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals . Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Job Information Job Opening ID ZR_1871_JOB Date Opened 14/04/2023 Industry Technology Job Type Work Experience 8-12 years Job Title Architect City Bangalore Province Karnataka Country India Postal Code 560048 Number of Positions 1 Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook and PI Vision Hands on experience in implementing, configuring and troubleshooting of OSI PI Interfaces including, but not limited to, OPC DA, PItoPI, RDBMS and UFL and has successfully implemented within several client projects. Good understanding of standards & protocols like ISA S88, ISA S95, OPC etc. Excellent working knowledge of OSI PI systems, including functional and technical features as well as limitations of OSI PI Product suite Responsibilities : IT-OT integrations including Industrial Connectors such as Kepware. Mentors System Analysts and can provide UAT & Validation support. Ability to work with all levels of the organization, both technical and non-technical. Good knowledge in Computerized System Validation, GAMP, GxP environments, Quality Systems. PI Data Access Methodologies AF SDK, OLEDB/ODBC/JDBC Provider, PI OPC DA/HDA Server, PI Web API Willingness to learn special and new technologies (Edge technologies and IoT). Experience and desire to work in a Global delivery environment. Level 100 & Level 200 Accredited preferred check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested