Job Description :
Apotech is looking to bring on an experienced Quality Consultant, specifically focused on QMS. Managing compliance activities and QA operational activities related to the operational projects as required by Good Manufacturing Practice (GMP).
- Manage deviations, anomalies, customer complaints, CAPA, change control
- Define the quality indicators
- Process validation (special or manufacturing)
- Write, review and manage the quality documentation (procedures, protocols, operating modes, …)
- Participate in pre-audits, audits and preparation for inspections
- Set up or update the QMS of the companies
Want to join a dynamic and innovative team, who are experts in Biotech/ Medtech?
Do you think you have the qualities and skills expected for this position? Apply through the link below…
- Advanced degree (MS, MBA, Ph.D.) preferred
- You are familiar with ISO9001, ISO 13485, and/ or GMP quality standards
- Experience in direct interactions with regulatory agencies during site inspections
- You are a dynamic person, with good interpersonal skills
- Speak English fluently