18 Gxp Compliance Jobs

You should have a minimum of 10 - 12 years of experience in handling complex large transformation projects. Your expertise should include Client Relationship Management with key client stakeholders, understanding their requirements, and the ability to meet them through outsourcing. You should also have experience leading large teams located across multiple cities in India and around the world. Additionally, you should have a proven track record of driving Digital Transformation across a portfolio of accounts while demonstrating a breadth and depth of operational service delivery management expertise. Preferred qualifications include the ability to create technical designs based on functional designs, such as mockups, process and data flow diagrams, etc. You should also be able to gather critical information from meetings with various stakeholders and produce useful reports, conduct market research for product development, and have knowledge of cloud platforms (Fundamentals of GCP/AWS/Azure), GDPR, HIPAA/GXP compliance, ERP, and SAP applications. As a part of the role, you will be responsible for leading the delivery of multi-functional, large-scale Cloud transformation projects. Your duties will involve conducting a thorough review of all components in the Project/Program Plan including scope, deliverables, time frame, and cost. You will be responsible for stakeholder management (both internal and external), managing risks, issues, scope changes, unplanned events, and other actions of the project, and tracking them regularly to ensure expected outcomes and timelines are met. You will work closely with Developers, Business Analysts, Quality Assurance, Engineering, and cross-functional teams to resolve issues that arise during design, implementation, and post-production. Additionally, you will collaborate with external and internal partners on integration and product expansion opportunities.,

You will be providing quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Your main responsibilities will include performing and delivering Quality Operations services to support product quality compliance and regulatory workflows, holding accounts in workflow applications to ensure proper execution of service deliverables, generating and analyzing predefined and ad-hoc reports in various applications, escalating service-related issues for timely investigation and compliance, ensuring compliance with internal quality standards and relevant regulatory requirements, and assisting in ad hoc administrative activities as required by the business. Additionally, you will focus on timely completion of all relevant and assigned trainings, learn and develop an understanding to generate insights through data and digital means, take responsibility and ownership of assigned tasks, ensure accuracy and timeliness of deliverables, comply with applicable Novartis operating procedures, provide support during internal and external audits, and adhere to current GxP and compliance policies of Novartis. Your key performance indicators will involve extracting data from relevant sources in Novartis tools/applications, interpreting and compiling external supplier APQR and/or extracted data from internal Novartis systems, interacting with CMOs and/or manufacturing sites, supporting in the updating and maintenance of APQR schedule, reviewing APQR reports/data for completeness and correctness, and completing APQRs within defined timelines. To be considered for this role, you should have an educational background in M.Pharm/MBA/Engineering or equivalent from a reputable institute, with a minimum of 1 year of experience in Quality Assurance, Regulatory, or in the manufacturing of pharmaceutical drug substances or products/medical devices. Basic awareness of GxP compliance requirements is also required. Novartis aims to reimagine medicine to improve and extend people's lives, with a vision to become the most valued and trusted medicines company in the world. By joining Novartis, you will be part of a mission-driven organization where associates are the driving force behind reaching ambitious goals. Novartis is committed to fostering an outstanding, inclusive work environment and building diverse teams that reflect the patients and communities served. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process or to perform essential job functions, please reach out to [email protected] with details of your request and contact information, including the job requisition number.,

As the Site QA Head at Sun Pharmaceutical Industries Ltd in Halol, your main responsibility will be to oversee and manage the quality assurance activities at the site. This includes tasks such as documentation review, SOP updates, in-process quality assurance, batch release, internal audits, compliance monitoring, and continuous improvement of quality systems, among others. You will be reporting to the Site Quality Head and will work within the Quality department. Your key responsibilities will involve defining the operational strategy and roadmap for quality assurance management at the site, setting quality assurance goals in line with compliance and regulatory requirements, managing resources effectively, identifying and implementing solutions for improving existing quality systems, and coaching and developing direct and indirect reports. Additionally, you will be responsible for developing budgets, ensuring compliance with regulatory requirements, preparing the site for inspections and audits, monitoring quality metrics, collaborating with other Sun Pharma sites, and ensuring smooth supply chain management. Your role will also involve designing and implementing quality-related SOPs, facilitating audits, monitoring industry trends, overseeing training requirements, and ensuring compliance with quality standards for computerized systems. To qualify for this position, you should have a B.Pharm/M.Pharm degree and at least 17 to 18 years of experience in Quality Assurance, specifically in OSD (Oral Solid Dosage) manufacturing. Overall, as the Site QA Head, you will play a crucial role in maintaining and enhancing the quality assurance processes at the Halol site, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems to deliver safe and effective drug products.,

Key Deliverables: Lead global ELN and lab data platform strategy Implement Biovia Holistic Lab and instrument integration Enable unified lab data for AI/analytics use Build and manage cross-functional digital lab team Role Responsibilities: Align ELN strategy with business goals Ensure GxP and regulatory compliance Guide agile teams on lab system delivery Collaborate with global IT and lab stakeholders

Key Deliverables: Lead digital infrastructure and compliance for over 2000 GxP Lab Instrument Controllers globally Drive end-to-end lifecycle management including qualification, patching, and vulnerability remediation Introduce modern lab technologies and tools aligned with Amgen's digital transformation roadmap Manage and coach cross-functional IS teams including software developers, validation engineers, and scrum masters Role Responsibilities: Define and execute technology strategy for Lab IT aligned with regulatory and business requirements Collaborate with global partners to enhance lab operations and improve scientific data systems Ensure system reliability, compliance, and secure operations across platforms and sites Foster innovation, diversity, and continuous improvement in a regulated biotech environment

Key Deliverables: Design, develop, and deploy GxP-compliant applications using Java and Salesforce Collaborate with product teams and architects to define and implement technical solutions Support integrated case management systems and resolve data transfer issues Facilitate user story breakdown and backlog management for agile sprints Role Responsibilities: Drive hands-on implementation and resolution of system performance bottlenecks Align business needs with functional solutions through effective analysis and documentation Mentor junior developers and review deliverables for quality and consistency Ensure adherence to regulatory and agile project management practices

Key Deliverables: Lead enterprise-wide Veeva Vault platform strategy and issue resolution Design scalable, compliant platform architecture with integrated data governance Drive cross-functional collaboration for configuration, integration, and continuous platform improvement Ensure Veeva DevOps standards and team performance across global operations Role Responsibilities: Manage support delivery and enhancement of Veeva Vault and its integrations Oversee team performance, stakeholder alignment, and GxP compliance Maintain platform documentation, standards, and impact assessments Provide strategic leadership on upgrades, innovations, and roadmap execution

Key Deliverables: Lead end-to-end software lifecycle and strategy for Quality tech platforms Ensure global compliance with GxP, Privacy, and regulatory technology standards Build and scale high-performing tech teams for validated system delivery Oversee stakeholder alignment, roadmaps, and cross-functional IS service execution Role Responsibilities: Drive technology vision and team development for Quality IT systems Collaborate globally across product owners, delivery leads, and compliance units Monitor product performance, governance metrics, and improvement loops Ensure budgetary discipline and alignment with Pharma business strategy

Key Deliverables: Lead validation strategy and execution for GxP-compliant IT systems Manage test protocols (IQ, OQ, PQ) and validation documentation lifecycle Ensure alignment with 21 CFR Part 11 and global quality compliance standards Collaborate on test automation, defect resolution, and system improvements Role Responsibilities: Interface with product owners and architects to define validation scope Track and resolve system defects across test cycles with cross-functional teams Provide system support and training to end users across platforms Maintain dashboards and reports to monitor test and validation outcomes

Key Deliverables: Create and execute IQ, OQ protocols ensuring GxP compliance Conduct manual and automated testing for functional and performance assurance Maintain validation documentation aligned with regulatory standards Collaborate on continuous improvement and automation initiatives Role Responsibilities: Validate integrated case management systems per SDLC and regulatory needs Report and manage defects with development and quality teams Identify tools to improve test automation and validation workflows Ensure traceability and compliance through structured change control

You will design & implement various innovative solutions in the realms of Clinical data management, analytics Work in clinical data management and analytics area as part of strategy building, assessment and technology implementation project as business and data analyst Lead and participate in clinical business process discussions with clients, identify requirements and user stories Conduct online interviews and workshops to gather requirements to support the business needs of users Author high-level user stories and develop related tasks, acceptance criteria and review test cases Participate in clinical business process discussions with clients, identify requirements and user stories Work closely with project teams in creating Requirement Specifications, RTM and other project documents Plan and facilitate various Agile meetings and artefacts, including sprint planning, review & retrospectives, daily stand-ups Perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules The ideal candidate will have a strong background in the project lifecycle, with experience in large and complex programs. They will have a track record of successfully managing people, and be able to provide support and escalation routes for queries, define and plan analysis deliverables, and agree on analysis approaches. Experience in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community is also essential. What you'll Bring bachelors degree Pharma/ Bioinformatics / Medicine or related disciplines Masters degree in Business Analyst, Engineering or Science preferred. 5-10 years of experience working within Life Science Domain as solution architect / business analyst / data analys t is required. Experience of working in building solution around drug development - clinical data management areas like discrepancy management, clinical data repositories, clinical issue management, Operational data repositories, operational reports Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Experience working in Clinical data management area as BA or Subject matter expert Understand the end to end process for clinical data management and Analysis Exposure to clinical data coordination and clinical data management area. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred.

Senior Data Engineering Manager Regulatory / IPT We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence solutions. Roles & Responsibilities: Functional Skills: Lead the engineering strategy and implementation for end-to-end regulatory operations, including data ingestion, transformation, integration, and delivery across regulatory systems Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into data engineering solutions Manage and oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (e.g., eCTD, IDMP, SPL, xEVMPD) Enable integration and reporting across regulatory information management systems (RIMS), EDMS, clinical trial systems, and lab data platforms Implement data governance, lineage, validation, and audit trails for regulatory data workflows, ensuring GxP and regulatory compliance Guide the development of automation solutions, dashboards, and analytics that improve visibility into submission timelines, data quality, and regulatory KPIs Ensure interoperability between regulatory data platforms and enterprise data lakes or lakehouses for cross-functional reporting and insights Collaborate with IT, data governance, and enterprise architecture teams to ensure alignment with overall data strategy and compliance frameworks Drive innovation by evaluating emerging technologies in data engineering, graph data, knowledge management, and AI for regulatory intelligence Lead, mentor, and coach a small team of data engineers and analysts, fostering a culture of excellence, innovation, and delivery Drive Agile and Scaled Agile (SAFe) methodologies, managing sprint backlogs, prioritization, and iterative improvements to enhance team velocity and project delivery Stay up-to-date with emerging data technologies, industry trends, and best practices, ensuring the organization leverages the latest innovations in data engineering and architecture Must-Have Skills: 812 years of experience in data engineering or data architecture, with 3+ years in a senior or managerial capacity, preferably within the biotech or pharmaceutical industry Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (e.g., Databricks, AWS, Azure, or GCP) Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments Ability to translate technical capabilities into regulatory and business outcomes Prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios Good-to-Have Skills: Prior experience working on integrated product teams or regulatory transformation programs Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices Education and Professional Certifications: 12 to 15 years of experience in Computer Science, IT or related field Scaled Agile SAFe certification (Preferred) Project Management certifications (Preferred) 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 Strong presentation and public speaking skills

Senior Data Engineering Manager Regulatory / IPT We are seeking a Senior Data Engineering Manager with a strong background in Regulatory or Integrated Product Teams within the Biotech or Pharmaceutical domain. This role will lead the end-to-end data strategy and execution for regulatory product submissions, lifecycle management, and compliance reporting, ensuring timely and accurate delivery of regulatory data assets across global markets. You will be embedded in a cross-functional Regulatory Integrated Product Team (IPT) and serve as the data and technology lead, driving integration between scientific, regulatory, and engineering functions to support submission-ready data and regulatory intelligence solutions. Roles & Responsibilities: Functional Skills: Lead the engineering strategy and implementation for end-to-end regulatory operations, including data ingestion, transformation, integration, and delivery across regulatory systems Serve as the data engineering SME in the Integrated Product Team (IPT) to support regulatory submissions, agency interactions, and lifecycle updates Collaborate with global regulatory affairs, clinical, CMC, quality, safety, and IT teams to gather submission data requirements and translate them into data engineering solutions Manage and oversee the development of data pipelines, data models, and metadata frameworks that support submission data standards (e.g., eCTD, IDMP, SPL, xEVMPD) Enable integration and reporting across regulatory information management systems (RIMS), EDMS, clinical trial systems, and lab data platforms Implement data governance, lineage, validation, and audit trails for regulatory data workflows, ensuring GxP and regulatory compliance Guide the development of automation solutions, dashboards, and analytics that improve visibility into submission timelines, data quality, and regulatory KPIs Ensure interoperability between regulatory data platforms and enterprise data lakes or lakehouses for cross-functional reporting and insights Collaborate with IT, data governance, and enterprise architecture teams to ensure alignment with overall data strategy and compliance frameworks Drive innovation by evaluating emerging technologies in data engineering, graph data, knowledge management, and AI for regulatory intelligence Lead, mentor, and coach a small team of data engineers and analysts, fostering a culture of excellence, innovation, and delivery Drive Agile and Scaled Agile (SAFe) methodologies, managing sprint backlogs, prioritization, and iterative improvements to enhance team velocity and project delivery Stay up-to-date with emerging data technologies, industry trends, and best practices, ensuring the organization leverages the latest innovations in data engineering and architecture Must-Have Skills: 812 years of experience in data engineering or data architecture, with 3+ years in a senior or managerial capacity, preferably within the biotech or pharmaceutical industry Proven experience supporting regulatory functions, including submissions, tracking, and reporting for FDA, EMA, and other global authorities Experience with ETL/ELT tools, data pipelines, and cloud-based data platforms (e.g., Databricks, AWS, Azure, or GCP) Familiarity with regulatory standards and data models such as eCTD, IDMP, HL7, CDISC, and xEVMPD Deep understanding of GxP data compliance, audit requirements, and regulatory submission processes Experience with tools like Power BI, Tableau, or Qlik for regulatory dashboarding and visualization is a plus Strong project management, stakeholder communication, and leadership skills, especially in matrixed, cross-functional environments Ability to translate technical capabilities into regulatory and business outcomes Prepare team members for stakeholder discussions by helping assess data costs, access requirements, dependencies, and availability for business scenarios Good-to-Have Skills: Prior experience working on integrated product teams or regulatory transformation programs Knowledge of Regulatory Information Management Systems (RIMS), Veeva Vault RIM, or Master Data Management (MDM) in regulated environments Familiarity with Agile/SAFe methodologies and DevOps/DataOps best practices Education and Professional Certifications: 12 to 15 years of experience in Computer Science, IT or related field Scaled Agile SAFe certification (Preferred) Project Management certifications (Preferred) 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 Strong presentation and public speaking skills

Senior Manager IT Quality Assurance Location: Hyderabad, India (Amgen India AIN) Work Type: On-site as per site policy Role Overview: This vital leadership role involves executing complex and novel IT QA assignments requiring strategic planning and innovative techniques. You will oversee GxP system reviews and risk assessments per Amgen's quality policies and regulatory standards. As Senior Manager, you will supervise and mentor staff across multiple IT QA workflows, with a focus on compliance, continuous improvement, and cross-functional collaboration. Focus Areas: Computer System Validation (CSV): In-depth knowledge of 21 CFR Part 11, EU Annex 11, and GAMP standards. Audit Trail and Periodic Review Oversight: Ensure compliance, system integrity, and risk assessment. Supplier Management: Oversee vendor selection, qualification, contract management, and software delivery. Quality Management System (QMS): Ensure compliance for computerized systems, maintain documentation, and drive process improvement. Key Responsibilities: Lead and mentor IT QA staff managing GxP activities across global time zones. Guide team in conducting periodic reviews and audit trail assessments. Manage validation processes, including change control, validation deliverables (e.g., Validation Plan, Test Strategy, Summary Report). Perform supplier management for computerized systems and other validated systems. Review and approve failure investigations and CAPA for computer systems. Act as Business Owner for QA-owned systems (e.g., SAP QM, Veeva, Kneat). Support regulatory inspections and act as quality contact. Utilize tools like HP ALM, Jira, Confluence, TrackWise, and document management systems. Additional Responsibilities: Apply risk-based decision-making to IT systems and processes. Determine system/process requirements and validate deliverables. Review SOPs, validation documents, and QMS records (Deviation/CAPA). Analyze complex problems using multiple data sources and analytical tools. Track and report on IT QA metrics, recommend quality improvements. Escalate critical decisions, ensuring timely resolution and compliance. Basic Qualifications: Master's Degree with a minimum of 10 years in Software & Systems Quality Assurance (including 5 years of team leadership ) OR Bachelor's Degree with a minimum of 14 years in Software & Systems Quality Assurance (including 5 years of team leadership ) Strong understanding of GxP compliance for information systems Familiarity with industry standards, SDLC principles , and cross-functional team leadership Willingness to work in different time zones or outside standard hours Preferred Skills: 35 years experience training others in QA activities listed above Demonstrated ability to develop and improve training programs Strong collaboration mindset and ability to work across functions

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product managers to ensure detailed and quality technical delivery in an Agile environment. You will maintain efficient development workflows, ensure robust testing practices, and uphold compliance with GxP and regulatory standards . Key Responsibilities Develop detailed test plans and strategies based on project requirements Perform manual and automated testing , including functional, regression, and performance testing Document and report defects/issues and collaborate with development teams for resolution Maintain documentation of test/validation plans, test cases, and results Validate test scenarios against acceptance criteria and customer expectations Ensure user stories and requirements are well documented in Jira Provide technical validation support to meet quality, cost, and troubleshooting objectives Prepare, execute, document, and report validation protocols compliant with GxP and regulatory requirements Ensure validation procedures align with corporate and government regulations Perform IQ, OQ, and PQ validations for processes, equipment, and systems, including supplier coordination when needed What We Expect of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Master's degree with 46 years of experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems OR Bachelor's degree with 68 years of experience in the above fields OR Diploma with 1012 years of experience in the above fields Functional Skills Must-Have: Strong problem-solving skills for complex technology challenges in drug discovery Experience with Agile methodologies (Scrum) Strong communication skills with ability to present to senior leadership Experience with validation , compliance , and data integrity standards Good-to-Have: Familiarity with cloud platforms (AWS, Databricks) and GCP regulations Experience with validation solutions in life sciences Ability to communicate complex subjects in business-friendly terms Experience with Jira Align Professional Certifications (Preferred) SAFe for Teams certification Soft Skills Works well under minimal supervision Excellent analytical and troubleshooting abilities Strong verbal and written communication Effective collaboration in global, virtual teams Initiative and self-motivation Ability to manage multiple priorities successfully Strong team orientation and public speaking skills Shift Information This position requires late, second, or third shift schedules Must be willing and able to work evening or night shifts as per business requirements

To develop, ensure, implement and maintain a GxP compliant Laboratory systems. To ensure training and effective implementation of current Good Laboratory Practices. To establish and ensure analysis, approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In house method for Oral Dosages and LVP facility. To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done. To Ensure the Maintenance of the Department, Premises and Equipment. To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved specifications and applicable guidelines. To ensure that the specifications and the testing methods are in line with the latest guidelines and applicable pharmacopoeias To approve specifications, sampling instructions, test methods & other Quality control procedures for oral and liquid injectable facility. To approve and monitor all contract analysis. To Ensure the required initial and continuing training of Quality Control personnel is carried out and adapted as per requirement. To assist in the investigations related to the laboratory, product failure, incidents and Risk assessments. Review and disposition of the non-conforming materials in co-ordination with Quality Assurance. To ensure the compliance of the Quality Management System and CAPA effectiveness related to the Laboratory. To apply total quality management tools and approaches to analytical and reporting processes. Create and direct environmental monitoring programs in line with the regulatory requirements. To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate. To monitor and report quality control progress, notify any discrepancies or potential concerns to the site Quality Head. Support the development of quality goals and targets as part of the organization s strategic plan. Maintain active role on internal continuous improvement initiatives. To Design, develop and implement quality control training programs. To ensure the self-training in the ISO train within the stipulated time frame. Business Administrator for Darius System, to ensure the review and approval of documents in Darius. To be responsible for Laboratory Quality management system and internal Audit as per NABL ISO/IEC 17025. In absence of the position holder, the Manager/ Group manager working in the respective section or shall be responsible for day to day working. Minimum Education M.Sc / B.Pharm / M.Pharm / Ph.D in pharmacy having relevant experience of around 15+ years in quality control functions in a formulation plant. Should have faced and managed regulatory audits such as USFDA / EU GMP independently

Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones. Develop, Mentor, and oversee staff and day-to-day GxP activities. Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews. Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.). Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.) Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat). Participation and support of regulatory inspections as needed. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems. The following are some examples of tasks for the position Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA). Review and Approve System Life Cycle Documents (i.e. Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipates and prevents potential problems. Independently develop solutions that are thorough, practical and consistent with functional objectives. Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance. Basic Qualification Masters degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR Bachelors degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration). Strong understanding and ability to apply GxP requirements in Information systems. Possesses a strong understanding of industry standards and business principles. Contributes to work group/team by ensuring quality of tasks/ services provided by self and others. Candidate may need to work hours outside the standard workday or work in different time zones to support business needs. Preferred skills Demonstrated experience (3-5 years) training others in activities outline above. Establish/Improve and actively participate in training curriculum and delivery of this material.

KEY RESPONSIBILITIES The incumbent will work closely with the Corporate Quality Assurance teams under the supervision of the Digital Business Partner, leading articulation of key technology and digital requirements and ensuring successful rollouts. More specifically s/he will lead the following responsibilities: Business Analysis: Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase. Collect data, analyse & define the business and user requirements. Analyse business problems and facilitate in IT solution evaluation. Work closely with managers and end users to have buy-in for the proposed solution. Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders. Categorize the functional and non-functional requirements of the business. Conduct post project implementation acceptance and requirements reviews. Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode. Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems. Should have knowledge of GxP system testing and validation. Sound communication skill with good amount of convincing power (intermediate level). An ideal candidate should be well planned and structured in his/her all deliverables. Must have experience in Pharma IT with hands-on expertise for handling GxP systems. IT Support and Maintenance: Provide IT administrative support for Enterprise systems but not limited to the following. User Management (Creation, Modification, Password reset etc.). User Access Rights Management. Active user list preparation. Support to Biocon users on the enterprise application on service requests, incidents and bug fixes. Periodic review of event logs (as where applicable). Provide support to vendor for fixing IT related issues during breakdowns. Responsible for adoption, creation and Maintenance of Quality Management Procedures as per IT Operation requirements. 1st level Point of Contact for all IT related queries from Biocon users for enterprise systems Co-ordination with Enterprise functional Team for finding the RCA from IT Perspective in their Incidents and CAPAs. Responsible for implement Change controls and log Incidents and deviation related to IT Functions. Responsible for adherence of SLA's defined for various IT administrative support activities. PROFESSIONAL EXPERIENCE / QUALIFICATIONS Bachelor's in Engineering or Master's degree in a related discipline, including a minimum of 4-6 years of experience gained in technology implementation in the Pharma space Specific experience as a Business Analyst in a GxP application for a pharma company Excellent oral/ written communication skills Self-starter, with the ability to work and execute independently with minimal oversight.