Quality Assurance Manager, South Cluster (fixed term contract)
About The Position
Medison is a global pharma company on a mission to help patients around the world get faster access to lifesaving, innovative, breakthrough therapies. We operate in 4 continents and over 25 countries and are growing fast. If you want to be part of our mission and help save patients by getting them the latest treatments, join us!
The QA Manager is an experienced professional and part of EPM QA team. Based in Greece, the QA Manager is supporting a number of territories, and will report directly to the Head of QA, EPM in Switzerland. You will play a vital role in designing and implementing a complaint quality management system across Greece and other territories, as well as actively participate in the EPM Quality Team.
This position is a one year fixed-term contract to cover maternity leave.
- This role will not only cover Greece but can be extended to other territories
- Participate in designing, implementing, maintaining, and improving quality system.
- Ensure the QMS is compliant to regulatory requirements
- Independently initiate and approve SOP updates and creation of new SOPs. Additionally oversee review of SOPs and associated documentation to ensure review requirements are met
- Provide hands on quality expertise to colleagues and partners to support their quality and business needs
- Participate in vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipment
- Work with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDP
- Ensure/participate in self-inspections of Medison GMP/GDP operations are performed to schedule and identified CAPA’s are closed to plan
- Participate in Medison Management Review to assess the effectiveness of the QMS and to highlight continuous improvements as appropriate
- Ensure change control requests, deviations, complaints and CAPA’s are reviewed using risk-based principals to comply with applicable requirements
- Participate in regulatory Inspections as required
- Participate in recall and mock recall operations
- Carry out any other duties that maybe reasonably required and assigned to you by your manager
- Bachelor’s Degree in science or equivalent
- At least 5 years’ experience in an active QA role
- Excellent written and verbal communication skills
- Fluent English is essential
- Attention to details
- Quality function representative on various projects
- Root cause analysis and investigation skills
- Technical report writing
- Strong knowledge in regulatory, cGDP and cGMP requirements
- Proven track record in auditing and quality systems
- Experience in regulatory inspections is desirable
- Strength in critical thinking, problem solving, and decision making
- Collaborative nature, self-directed and independent
- Very strong organizational abilities