SIRO Clinpharm Pvt. Ltd.
Website:
siroclinpharm.com
Job details:
· Strong expertise in Werum PAS-X MES MBR,GMBR,PMBR,etc. designing and Validation
· Knowledge of pharmaceutical manufacturing processes and regulatory compliance (GMP, GAMP 5, CFR Part 11).
· Experience with MES with ERP (SAP), L2/L3 automation systems, and serialization platforms, ISA 85 and 9.
· Understanding of data integrity principles and validation processes..
Roles & Responsibilities
· Design and configure Master Batch Records (MBRs) in Werum PAS-X according to client manufacturing processes.
· Collaborate with process engineers and QA teams to ensure compliance with GMP and data integrity.
· Validate and test MBRs to meet regulatory and operational requirements.
· Support MES implementation projects and troubleshoot issues related to MBR design.
· Work closely with cross-functional teams to harmonize processes and promote standardization across sites.
Generic Managerial Skills
Strong analytical and problem-solving skills.
Excellent communication and documentation abilities.
Ability to work in a regulated environment and manage multiple priorities
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