Quality Assurance Manager

Alliance Healthcare Türkiye

We are seeking to appoint a Quality Assurance and Health & Safety Manager to support our pharmaceutical wholesale operation. This critical position will provide leadership, direction and implementation of Quality Assurance and Health & Safety policies and strategic development within complex pharmaceutical wholesale environment. 

Desired Skills & Experience for the Quality Assurance Manager:

• Degree level studies in Science (ideally Pharmacy) 
• In depth experience of working in a QA or QC role within a regulated environment, ideally working at a pharmaceutical storage and distribution operation. 
• Good knowledge and understanding of GMP/GDP and relevant Ministry of Health guidelines. 
• Experience in the following would be advantageous:
  • Validation (storage areas, vehicles, packaging materials etc) and temperature mapping
  • Document administration and control systems
  • Interaction with regulatory groups
• Self motivated and enthusiastic, can work independently.
• Flexibility (will be working in a fluid business environment where priorities may change frequently)
• Ability to travel frequently (domestic).

JOB DESCRİPTİON 

Key accountabilities for the Quality Assurance Manager include:

• Establishing and managing Quality Management System
• Routine QA activities (deviations, change control, CAPA, self-inspection)
• Development and management of document control systems
• SOP and other document (risk assessments, technical and quality agreements) writing, review and revision
• Co-ordination and control of certification/release procedures together with QPs
• Monitoring and management of QA aspects
• Support for auditing activities
• Preparation of sites for inspection (GMP/GDP) by regulatory authorities.
• Deliver the health and safety policy in a practical and proportionate way,
• Undertake risk and safety assessments and provide support to areas requiring specialist technical assistance
• Maintain reporting systems and data for H&S events,
• Develop accident/incident reduction techniques and share learning to identify trends that reduce risks,
• Educate lead team in reporting and monitoring safety hazards,
• Support, Develop and ensure a robust audit programme is in place both for sound risk management and assurance purposes. 

This is an exciting opportunity to join a highly innovative and expanding  pharmaceutical wholesale company, where your efforts will directly influence the quality of the services provided.