Operational Quality Specialist - MES
Core
Ensure adherence to cGxP standards through independent oversight of GxP processes and provide operational quality assurance for Manufacturing Execution System (MES) activities supporting drug product manufacturing.
Role type
Operational Quality Specialist (MES)
Builds
Manufacturing Execution System workflows, electronic batch records, and system-controlled manufacturing steps for pharmaceutical production.
Domain
Biopharmaceutical manufacturing / Quality Assurance / Computerized Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP regulations, MES implementation, validation principles, root cause analysis (DMAIC), data integrity, change control, CAPA, risk assessment, regulatory compliance (GMP/FDA/21 CFR Part 11)
Preferred skills
biologics manufacturing, electronic records guidance (Annex 11), LIMS, system lifecycle tasks
Technologies
MES, SAP, OsiPi, electronic batch records, LIMS
Responsibilities
Provide operational QA oversight for MES workflows and electronic batch records; Review and approve creation/updates to master data (Equipment Spec File, sMBR, URS, Design); Approve validation forms and protocols for Main-PI/Sub-PI; Lead or support investigations for deviations and system incidents; Perform shopfloor walkthroughs to identify risks; Monitor MES-related quality KPIs and recommend improvements.
Seniority
Mid-level, hands-on IC
