Maria Alexieva

Planning and execution of worldwide internal audits at Fresenius Kabi organizations and country subsidiaries according to EU and FDA GMP regulations, WHO, ICH Guidelines, Pharmacovigilance regarding medicinal products and medical devices, ISO 13485, and ISO 9001.

Key responsibilities:

- Audit Lifecycle: Planning, scheduling, performing and follow-up of Global Internal Audits at:

• Manufacturing sites for Pharmaceuticals and Medical Devices
• Marketing sites with vital functions regarding customer service: communication, product distribution, product training and after-sales service, handling of complaints
• Pharmacovigilance and Regulatory Affairs functions: NSO, ADRs, PSMF, Safety Variations etc.
• Large scale Compounding Pharmacies for preparations of a custom formulation for unique patient need

- Preparation of trends from health authority inspection results

- Improvement of inspection readiness

- Performing training in various GMP topics for auditors and regular employees

Project Lead:

• Implementation of a new global IT system for audit management
• Maintenance, user management and training of global audit management system
• Preparation of CSV documentation and execution of validation activities regarding the audit management system

Process owner of supplier qualification system, quality assurance oversight of the local production unit, inspection management and readiness, implementation of corporate requirements

Key responsibilities:

· Supplier qualification: preparation of the annual audit plan for suppliers, monitoring and evaluation of suppliers, preparation of quality agreements with suppliers, follow up of corrective und preventive actions from the supplier audits, qualification of auditors

· Self-inspection program: preparation of the annual plan, execution of the self-inspections and flash checks

· Inspection management: hosting of health authority inspections and customer audits; consolidation of consequential corrective und preventive actions (CAPA)

· Representing Merck KGaA at the JAVfX (Joint Audit Verfahren für X= Excipients or Packaging Materials)

· Implementation of regulatory and corporate requirements and KPIs

· Processing of change controls, deviations, and complaints

· Quality Assurance review of documents regarding cleaning and process validation

Quality Assurance oversight of external packaging of clinical study medication (IMPs)

Key responsibilities:

· Supervising and guaranteeing all aspects of QA and timelines for external contract manufacturer

· Review of batch record documentation

· Approval of Master Batch Records

· Preparation of batch release for the Qualified Person

· Handling of deviations and technical complaints