Quality Manager

• Establish, lead and manage new Quality Team of ~5 persons based on site, comprising of Quality Assurance and Quality Control producing Excipients, Pharma and Biopharma raw materials.
• Take overall responsibility for site QA and QC functions to meet Regulatory, customer and certification requirements.
• Act as site lead for implementation and ongoing maintenance of certifications for excipient GMP manufacturing.
• Maintain oversight of all sourcing, manufacturing and storage/distribution including:
• 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)
• Lead implementation of applicable food and pharmaceutical law requirements and maintain oversight of compliance.
• Supervise and support laboratory through initial setup phase and in subsequent routine day to day operations.
• Procurement of equipment, implementation of SOPs, method verification etc.
• Lab adherence to site standards and GLP
• Oversight of annual budget for consumables
• Appropriate allocation of time / resources to analysis based on business priorities
• Recruitment and training of new personnel as team grows.
• Supervision of deviation management related to food & pharma production.
• Further development and oversight of CAPA management to drive Quality improvements in food and pharma production plant.
• Supervision of internal change management processes and approval of significant changes.
• Management of Quality related risk assessments related to production activity.
• Lead 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.
• 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).
• Contact person for engineering, production and quality control in quality relevant aspects on site.
• 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.
• Lead member of site GMP team.

Požadujeme

• 3rd level education in life sciences or related subject
• Fluent in Czech, fluent in English
• Experience in both laboratory (QC) and Quality Assurance / Management, able to supervise as support both in a small team.
• Previous experience in leading implementation and maintenance of Pharmaceutical Quality Management Systems (HACCP / GDP / GMP / EXCiPACT / IPEC), preferably in manufacturing company.
• General knowledge of nutraceutical and pharmaceutical (APIs, Excipients and raw materials) requirements and regulations.
• Specific knowledge and understanding of excipient manufacturing and regulatory requirements.
• 7 years previous experience in Quality Management / Quality Assurance

Desirable

Previous experience with SUKL

Nabízíme

Working for a large multinational, in your new role you will take the lead for all Quality aspects at a modern state of the art Excipient and Pharmaceutical Raw Material manufacturing site. 

Leading the site Quality function, you have the opportunity to establish a new site Quality team in line with your vision, and shape and execute the local Quality strategy while aligning with global standards and regional objectives.