QA Specialist

MISSION STATEMENT

Main Job Purpose

:

• Put in place and maintain a high level of Quality for GMP/GDP topics
• Manage, with the FvP , the implementation and maintenance of an appropriate quality system covering primarily all GxP regulated activities related to development, manufacturing, distribution and commercialization of health care goods and their associated services and solutions.
• To perform quality lifecycle management for dedicated products for Swiss market.
• To take all necessary actions to secure the quality of the products and patient safety. MAIN ACCOUNTABILITIES AND DUTIES Quality system management
• Implement and maintain a local quality system applying primarily to SwissMedic-regulated activities related to the import and distribution of products and controlled substances
• Assure compliance with local regulations in Switzerland, international GDP / GMP requirements and the company
• Write SOPs and relevant documents, manage them in eDMS (electronic Document Management System) and support in implementation by training employees
• QA GMP, systems: GMP and process trainings, personal file maintenance
• Providing support to ensure inspection readiness and participation on internal audits and HA inspections
• QA POs executions in Fiori Product Quality Management
• Preparation of Market release of purchased or repacked products for Swiss Market: Str. 2 ZENTIVA JOB DESCRIPTION o Ensure completeness of batch documentation for batch release and request relevant documents form the suppliers or internal stakeholders, if necessary o Evaluation of CoA/CoC (Certificate of Analysis/ Certificate of Compliance), temperature records and packaging materials
• Request and manage Product Quality Reviews in a timely manner, perform reviews and evaluate compliance based on the local regulations in Switzerland
• Product database maintenance (Quality Forward): Keep up-to-date database on locally managed products and third parties Product related quality events, complaints and risk management
• Raise any concerns on batch release (product or process) to the FvP and implement appropriate solutions as agreed with the FvP
• Manage temperature excursion during transport
• Manage product-related deviations, complaints and other quality related issues including any CAPAs in a timely manner
• Provide support in any product related quality events by collecting information and documenting cases The employee will perform other tasks under the direction of the Manager within the agreed type of work.