Quality Assurance Specialist

You will help drive the Quality and Pharmaceutical Management System

• Raw material control (testing plan, traceability of products, residue control, internal approval for production, audits, GDP, HACCP, etc.)
• Production control (daily checks, process control, issue of daily production documentation, change management, internal audits, GMP & HACCP, etc.)
• Control of finished products (testing plan, analytical and sensory control, product release)
• Support implementation of applicable food and pharmaceutical law requirements and maintain oversight of compliance.
• Previous experience with SUKL
• Provide quality supervision as a regular (daily) presence in the Food and Pharma production areas, carrying out or ensuring:
• Coordination of deviation management related to food & pharma production.
• Coordination of CAPA management to drive Quality improvements in food and pharma production plant.
• Coordination of internal change management processes and approval of significant changes.
• Completion of Quality related risk assessments related to production activity.
• Participation in internal audit program.
• Collaborate with other departments (i.e. Production, Maintenance, QC, Purchasing) on the design and implementation of site qualification, validation and verification plans.
• Provide training of quality relevant topics (e.g. hygiene, records, traceability, GMP controls, HACCP prerequisites), including updating of the training matrix of production employees.
• Support in the creation of process documents for area of responsibility (Production GMP/Food).
• Participation in production meetings on Quality topics and updating on production related Quality KPIs.
• Internal approval of suppliers and raw materials for food and GMP production.
• Review of batch records and final batch release.
• Member of site GMP team.
• Participate in 3rd party certification / customer audits and regulatory authority inspections.
• Deputise for QA Manager.

Požadujeme

• 3rd level education in life sciences or related subject
• Fluent in Czech, fluent in English
• ISO / HACCP / GDP / GMP / EXCiPACT / IPEC experience, preferably in manufacturing company
• Knowledge of nutraceutical and pharmaceutical (APIs, Excipients and raw materials) requirements and regulations.
• 3 years previous experience in Quality Management / Quality Assurance
• Trained internal auditor

Nabízíme

Working for a large multinational, in your new role you will be a key part of the Quality team at a modern state of the art Excipient and Pharmaceutical Raw Material manufacturing site. 

You will help drive the Quality and Pharmaceutical Management System performance to meet KPIs, ensure customer satisfy and the safety of our products.