24x7 Manufacturing Support | Biopharmaceutical Industry
Position
Module
SAP PP-PI (Production Planning
for Process Industries) with QM
Experience
5-7 years (relevant SAP
experience)
Industry
Pharmaceutical / Biotech -
process manufacturing (GMP)
Engagement
- Production support for 24x7
- manufacturing operations
- Work schedule
- Rotational shifts / on-call;
- weekend and holiday support for critical incidents
Location
Chennai / Banglaore
About the Client
Our client is a global biopharmaceutical
- company focused on the development and manufacture of biosimilar medicines. SAP
- is their enterprise ERP platform, covering manufacturing, quality management,
- planning, production scheduling, warehouse management, finance and HR. Their
- GMP manufacturing plants operate 24x7, and the SAP landscape supporting them
- must be available and stable around the clock.
Role Summary
- We are looking for an SAP PP-PI consultant
- with strong Quality Management (QM) knowledge to provide 24x7 functional
- support for process manufacturing at a biopharmaceutical client. The consultant
- will keep production orders, batch execution and quality processes running
- smoothly on the plant floor, resolve incidents quickly, and drive continuous
- improvements in a GMP-regulated environment.
Key Responsibilities
•Provide
L1.5, L2/L3 functional support for SAP PP-PI and QM, resolving incidents and
service requests within agreed SLAs
•Support
process order lifecycle: creation, release, material staging, confirmation,
goods movements, settlement and TECO
•Maintain
and troubleshoot master data: master recipes, resources, BOMs, production
versions, control recipe destinations
•Support
PI sheets / XSteps and integration with MES and shop-floor systems
•Support
batch management: batch classification, batch determination, shelf life /
expiry, batch where-used and genealogy
•Handle
- QM processes: inspection plans, inspection lots (incoming, in-process, final,
- stability), results recording, usage decisions, quality notifications and
- certificates of analysis
•Support
release and quarantine processes in coordination with QA and the warehouse
•Perform
root-cause analysis on recurring issues and implement permanent fixes through
the GxP change-control process
•Prepare
functional specifications, test scripts and validation evidence (IQ/OQ/PQ, UAT)
for changes and enhancements
•Work
closely with PP-DS, EWM, MM and FI/CO consultants on cross-module issues
Required Skills and Experience
•5-7
years of SAP experience with hands-on PP-PI in a process industry (pharma,
biotech, life sciences, chemicals, food or similar)
•Strong
working knowledge of SAP QM integrated with PP-PI
•At
least one production support engagement and preferably one full-cycle
implementation
•Solid
understanding of batch management, process orders, master recipes and goods
movements
•Working
knowledge of GMP and GxP, computer system validation (CSV), 21 CFR Part 11 and
EU Annex 11
•Ability
to read and debug basic configuration, user exits and IDocs with technical
teams
Preferred / Added Advantage
•Pharma
or biotech manufacturing experience
•Exposure
to MES integration and SAP ME/MII
•Working
knowledge of PP-DS, EWM or MM
•Experience
on SAP S/4HANA in addition to ECC
Work Conditions
•This
- is a 24x7 production support role for live GMP manufacturing operations. The
- candidate will work in a rotational shift / on-call model as agreed with the
- client.
•Must
be flexible to work on weekends and public holidays when a critical (P1/P2)
incident affecting manufacturing needs to be resolved.
•Must
follow ITIL-based incident, problem and change management, and the client's GxP
change-control procedures.
•Must
be able to work with global, multi-time-zone teams including business users,
IT, QA/compliance and other SAP module consultants.
Soft Skills
•Clear
- written and spoken English; able to explain issues and fixes to shop-floor, QA
- and business users
- •Calm,
- structured approach under pressure during production-down situations
•Strong
root-cause analysis and documentation discipline (RCA, KEDB, SOPs, test
evidence)
•Ownership
mindset: follows an incident through to closure and permanent fix
•Bachelor's
degree in Engineering.
•SAP
certification in the relevant module is preferred
•Valid
passport and willingness to travel to client sites for short periods if
required
Job description provided by SRM Technologies.
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