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Experience: 58 Years Location: Hyderabad Hybrid, Willing to Travel atleast 50% Function: SAP Consulting, CSV and GxP Compliance Industry: Pharmaceuticals and Life Sciences About The Role We are looking for a confident and hands-on SAP ERP Functional and Validation SME with strong experience in pharmaceutical or life sciences environments. The candidate should have practical knowledge of SAP ECC, SAP S/4HANA and the wider SAP ecosystem, along with strong experience in Computer System Validation, SAP documentation, testing and training. This is not a documentation-only CSV role. The person must understand how SAP business processes are designed, configured, integrated, tested, validated, deployed and maintained. Key Responsibilities - Act as the SAP Functional SME for GxP-regulated SAP programmes involving ECC, S/4HANA and related SAP applications. - Provide functional expertise in at least two modules such as QM, MM, PP/PP-PI, WM/EWM, SD or PM/EAM. - Understand end-to-end SAP processes across procurement, manufacturing, quality, warehousing, distribution and maintenance. - Review requirements, process designs and SAP configurations for business and compliance suitability. - Support SAP implementation, rollout, upgrade, carve-out and ECC-to-S/4HANA transformation programmes. - Participate in fit-gap, fit-to-standard, process-design and validation workshops. - Assess GxP impact and define revalidation strategies for ECC-to-S/4HANA migrations. - Review SAP standard functionality, configuration, custom developments, interfaces, reports, forms and security controls. - Prepare and review SAP documentation, including: - Business process and functional design documents. - Configuration specifications and workbooks. - WRICEF or RICEFW inventories. - Interface and data-migration specifications. - Role and authorisation matrices. - Cutover, deployment and operating procedures. - Lead CSV activities, including: - Validation plans. - GxP assessments. - URS and functional specifications. - Risk assessments. - IQ, OQ, UAT and PQ protocols. - Traceability matrices. - Validation summary reports. - Ensure compliance with 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and ALCOA+ principles. - Define and review unit, integration, regression, OQ, UAT and PQ testing. - Support defect assessment, retesting and GxP impact evaluation. - Validate SAP data migration, interfaces and integrations with MES, LIMS, QMS, eQMS and WMS. - Develop and deliver SAP ECC and S/4HANA training for business users, key users and support teams. - Create training plans, user guides, SOPs, work instructions, job aids and train-the-trainer materials. - Independently lead client workshops, process walkthroughs and validation reviews. - Challenge unclear requirements, weak controls and unnecessary customisation. - Support client audits and regulatory inspections. - Mentor junior consultants and contribute to proposals, estimation and solution design. Required Experience And Skills - 58 years of SAP ERP consulting, implementation, validation or support experience. - Strong experience within pharmaceutical, biotechnology, medical-device or regulated life sciences environments. - Functional expertise in at least two SAP modules, preferably QM, MM, PP/PP-PI, WM/EWM, SD or PM/EAM. - Practical experience with SAP ECC. - Exposure to at least one SAP S/4HANA implementation, conversion, rollout or assessment. - Hands-on experience with SAP functional, configuration, testing and validation documentation. - Experience with SAP data migration, integrations, testing and change control. - Experience developing and delivering SAP user training. - Strong understanding of CSV, GAMP 5, Annex 11, 21 CFR Part 11 and data integrity. - Strong client-facing, documentation, communication and stakeholder-management skills. - Bachelors degree in Engineering, Pharmacy, Life Sciences, Computer Science, IT or a related discipline. Mandatory Certification - The candidate must hold at least one valid SAP certification relevant to the role. - Preferred areas include SAP S/4HANA, QM, MM, PP/PP-PI, EWM, SD, PM/EAM or SAP Activate. Behavioural Expectations The Candidate Should Be - Confident, bold and assertive in client discussions. - Comfortable challenging incomplete requirements and poor design decisions. - Decisive and able to provide clear recommendations. - Structured, accountable and detail-oriented. - Pragmatic in balancing compliance with business needs. - Capable of independently leading SAP functional and validation workstreams. Positive to Have - Experience with SAP Fiori, SAP BTP, SAP Integration Suite, SAP Solution Manager, SAP Cloud ALM, SAP GRC or SAP Signavio. - Experience with global SAP rollouts, carve-outs or acquisitions. - Familiarity with Computer Software Assurance and automated testing. - Awareness of AI and automation opportunities in SAP validation and documentation. .