eMonkGlobal
Website:
emonkglobal.com
Job details:
Experience: 5–8 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
- 5–8 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.
- Bachelor’s 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.
Good 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.
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