Pleno Quality Assurance Analyst (GMP)
Core
Ensure product safety and compliance with GMP standards, manage non-conformities, and support audits in a pharmaceutical excipient manufacturing environment.
Role type
Mid-level Quality Assurance Analyst (GMP)
Builds
Pharmaceutical excipients and plant-based ingredients
Domain
Food & Beverage / Pharmaceutical Manufacturing
Required skills
GMP knowledge, ISO 9001/FSSC 22000/RDC 34 familiarity, root cause analysis, batch release evaluation, customer complaint management, training delivery, technical reporting, inventory control, pest control monitoring, audit support
Preferred skills
Datasul ERP knowledge, public speaking, advanced English (via careerplan.io/jobs/R0026456-pleno-quality-assurance-analyst-gmp-at-roquette)
Responsibilities
Monitor pest control services and analyze inspection reports; Manage customer return occurrences and evaluate returned material for safety; Control rejected product areas and material flows; Perform GMP checklist inspections and generate non-conformance reports; Conduct Gemba Walks in production processes; Evaluate finished product batch dossiers for GMP compliance and release/reject batches; Resolve quality system pending items; Support year-end inventory counts; Address production process issues (PCC, PPROs, packaging deviations) and open deviation reports; Support internal, customer, and regulatory audits; Develop and conduct GMP training programs; Manage customer complaints and root cause investigations in Salesforce; Participate in global weekly key user meetings regarding complaints.
