4 Gxp Systems Jobs

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity Work experience in Pharma or IT Sector will be desirable Roles & Responsibilities Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites. To liaise with Site IT , Business SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities. To work along with Business, IT, QeC & Project Manager to ensure project timelines are met. Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. Competencies Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must) Experience of working with Global Pharma Cross functional Sites QC, QA, Manufacturing, IT, SAP etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

Be the First to Apply Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview The Deputy Manager - Business Application acts as the liaison between PCC system users, Software support vendors and internal PCC IT support teams. The ideal candidate will be a technical contributor and advisor to the PCC business users to proactively assist in defining strategic application development and integration to support business processes. Key Stakeholders: Internal Sales, Supply Chain, Finance, IT Infrastructure, Info Sec, Corporate IT teams Key Stakeholders: External Vendors, Consultants, Product companies Reporting Structure Reports to: Manager - IT Business Applications Education Qualification & Experience B.S. in Information Technology, Computer Science or equivalent 1-2 years of relevant experience in leading Business Applications Projects as a Business Analyst/Project Manager Experience in the Pharmaceutical or Medical Device preferred Global enterprise software experience dealing with large global software platforms such as CRM, SAP Strong Project Management experience, PMP or other advanced certification preferred Understanding of computer system validation lifecycle and working with GxP systems preferred Familiarity with project management tools (e.g. JIRA, Timesheet Systems) and office tools (e.g. Word, Excel, and PowerPoint) Good understanding of cloud based systems like salesforce.com or financial systems like Budgeting tool Experience in managing teams, with excellent team-working skills (especially in a culturally diverse environment) and a willingness to get alongside issues, provide clear direction and drive results. Experience in working with stakeholders in global geographies Training experience to assist system users to trouble-shoot issues; ability to produce training materials and lead training sessions. Ability to develop and create compelling business cases to promote new technologies and outcomes to the business Roles & Responsibilities Work with users to define user requirements, functional requirements and technical specifications and obtain business sign-off of requirements Support implementation of business applications/systems related to Supply Chain/Legal/Sales/Finance Manage rollout of multiple business specific applications Manage IT project team and external application vendor team during the roll out of IT projects/systems Maintain partnership with business teams and act as IT SPOC to business Work with business users to review proposed design solutions and determine if solution meets business needs Transfer knowledge to IT Support Team & manage change requests Communicate & coordinate changes in system into effected business areas for smooth transitioning & participate in the development, implementation & roll-out of system Projects Onboard vendors and manage external vendor teams to support the ongoing business applications Propose IT budgets (OPEX & CAPEX) in accordance with internal procedures, ensuring best value and quality Ensure customer satisfaction & build ongoing relationships with stakeholders and manage their expectations Develop a Deep understanding of PCCs approach to software development Collaborate with Corporate/Central IT teams IT security, IT infrastructure, SAP, Validation team to implement Business specific application/systems Responsible for working technical teams to ensure integration of different systems, proper data migrations Present monthly status update of Projects to IT Steering committee Provide Daily update to Manager on Day to Day activities and to Senior Management during governance calls Competencies Positive attitude with excellent interpersonal and communication skills (written, verbal, presentation) Self-motivated individual who can excel with little supervision and the proven ability to be successful in a fast paced, dynamic environment Excellent presentation and communication skills Ability to effectively communicate business needs to the technology teams Strong service focus - with a proactive customer service attitude Ability to lead teams and work collaboratively to achieve results About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Job Info Job Identification 9352 Job Category Information Technology Posting Date 08/22/2025, 01:33 PM Job Schedule Full time Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN Show more Show less

Roles Responsibilities: Develop and maintain design development activities and deploy applications to support GxP system Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Collaborate with cross-functional teams including product management, development, QA, and business analysts to gather and align stakeholder requirements Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Provide hands-on technical guidance to development teams across the software development lifecycle (SDLC) Maintain knowledge of trends in application development frameworks and related new technologies to provide, recommend, and deliver standard methodology solutions What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills Must-Have: Experience with business analysis, writing user requirements and acceptance criteria in agile project management systems such as JIRA Collaborate with architects and senior developers to define application and infrastructure strategy Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Ability to mentor, guide, and review work of junior developers and team members Good to Have: Experience in HP ALM, JIRA, ServiceNow Suite and document management systems (e. g. Veeva) Excellent problem-solving skills. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. Experienced in managing GxP systems and implementing GxP projects Ability to explain technical concepts to non-technical clients Experience using and adoption of Scaled Agile Framework (SAFe). Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. 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. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams

The Business Analyst position at Piramal Critical Care (PCC) within the IT department in Kurla, Mumbai involves acting as a liaison between PCC system users, software support vendors, and internal IT support teams. The ideal candidate is expected to be a technical contributor and advisor to PCC business users, assisting in defining strategic application development and integration to support business processes effectively. Key stakeholders for this role include internal teams such as Supply Chain, Finance, Infrastructure, PPL Corporate, and Quality, as well as external stakeholders like the MS Support team, 3PLs, and Consultants. The Business Analyst will report to the Chief Manager- IT Business Partner. The ideal candidate should hold a B.S. in Information Technology, Computer Science, or equivalent, with 8-10 years of experience in Data warehousing, BI, Analytics, and ETL tools. Experience in the Pharmaceutical or Medical Device industry is required, along with familiarity with large global Reporting tools like Qlik/Power BI, SQL, Microsoft Power Platform, and other related platforms. Knowledge of computer system validation lifecycle, project management tools, and office tools is also essential. Key responsibilities of the Business Analyst role include defining user and technical requirements, leading implementation of Data Warehousing, Analytics, and ETL systems, managing vendor project teams, maintaining partnerships with business teams, and proposing IT budgets. The candidate will collaborate with IT and business teams, manage ongoing business applications, ensure system security, and present project updates to the IT Steering committee. The successful candidate must possess excellent interpersonal and communication skills, self-motivation, proactive customer service attitude, leadership abilities, and a strong service focus. They should be capable of effectively communicating business needs to technology teams, managing stakeholder expectations, and working collaboratively to achieve results. Piramal Critical Care (PCC) is a subsidiary of Piramal Pharma Limited (PPL) and is a global player in hospital generics, particularly Inhaled Anaesthetics. PCC is committed to delivering critical care solutions globally and maintaining sustainable growth for stakeholders. With a wide presence across the USA, Europe, and over 100 countries, PCC's product portfolio includes Inhalation Anaesthetics and Intrathecal Baclofen therapy. PCC's workforce comprises over 400 employees across 16 countries and is dedicated to expanding its global footprint through new product additions in critical care. Committed to corporate social responsibility, PCC collaborates with partner organizations to provide hope and resources to those in need while caring for the environment.,