- Support the implementation of quality systems strategy and activities to support Medicinal goals .
- He/she will act and lead the integration of quality requirements into the business processes.
- The MQC will implement the quality plan & ensure consistency between the global & local requirements.
- This includes the draft of (SOPs) & assuring this system is aligned with quality & regulatory needs
- The MQC will provide updates on all GxP trends and changes through the Quality Lead Team systems
- He/she will act as a contact person regarding quality & business compliance concerns
- Ensure local implementation of the Quality System
- Review regional and/or local SOPs versus global policies. Reviews SOPs & provides feedback.
- Approve regional and/or local procedures, job aids, forms, templates
- Recommend new procedures or changes to existing procedures where applicable.
- Provide quality oversight for compliance to SOPs
- Escalate compliance issues to management locally and globally as appropriate,
- Provide support for outsourced activities in alignment with internal standards
- Ensure inspection readiness and compliance to global, regional, and/or local regulations
- Assist in interpreting relevant regulations & guidelines & act as a contact person for affiliates
- Perform quality self-assessments
- Facilitate audits and inspections
- Coordinate audit responses including Trackwise system documentation
- Communicate and ensure inspection readiness requirements are in place (such as) :
- Organization & availability of documents such as training records, job descriptions etc.
- Ensure the implementation and maintenance of Quality Plan(s)
- Document the quality systems requirements ensuring clear accountabilities.
- Manage the quality plan(s).
- Provide updates to quality and business owners.
- Implement and manage Quality Systems
- Provide consultation on the integration of quality into business processes.
- Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
- Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
- Ancilliary duties.
- Handles confidential information (patient privacy, confidential audits & regulatory inspections).
- Understand the roles and responsibility of the EU qualified person
What you'll need !
- B.Sc/M.Sc in a science or health care related field, Health professional, i.e., Pharmacist/Reg Affairs.
- Fluency in German is essential.
- 2-3 years (minimun) in quality and/or regulatorymedical affairs within private industry
- Demonstrated ability to implement & apply quality systems in a regulated environment (e.g. GCP, GvP).
- Some flexibility around work related travel required.
For full details on this role please call Colin on 021-4315770 or mail email@example.com today !
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