Job Description

Roles & Responsibilities:

Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
Well versed with Manufacturing, Quality and engineering system and their validations.
Knowledge of Pharmaceutical / Life Sciences as domain.
OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus).
Experience to MES, QMS (Track wise), Lab solutions i.e. LIMS, Empower CDS, Chrome L on, Business Analytics, Middle wares etc. will be an advantage.
Client/DCS Qualification.
ISA95 High level of understanding.
OT Security will be a plus.
Standalone Systems Qualifications.
Client/DCS Integrated with Manufacturing Equipment qualification.
Stakeholder management and good executor with required communication.

Job Tags

Work alone,

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