Aya Ben Kram

• Perform shipping product release for GI products for all countries

• Prepare batch documentation and review for EU QP release.

• Assure that the distribution of the products is conform to Good Distribution Practices, internal Quality standards and other applicable regulatory standards.

• Review of SOP for GDP and release and process improvement

• Support deviation investigation and complaint and sample checks

• Review of QAA with third parties and affiliates to ensure qualification

• Review of batch documentation, deviations, and change requests

• Collaboration in GMP-compliant documentation and release preparation

• Reviewing, assessing, and approving manufacturing documentation

• Responsible for the release of medicinal product to the market

• Processing, assessing, and approving deviations, corrective actions (CAPAs), and technical change requests -

Conducting quality floor walks and self-inspections, and supporting internal audits and regulatory inspections

• Support continuous process improvement and their implementation

• Close collaboration with Production, QC, SCM, and Regulatory Affairs

• Systematic tracking of CAPAs and change control documents through KPI

• Lead complex projects and quality initiatives

• Participation in internal audits, preparation of documents for regulatory or customer audits

• Preparation of PQR for different products within the company

• Follow up on CAPAs and NCMRs and change control cases

• Follow up and support the implementation of MDR compliance within the QMS

• Verification of processes for distributors and importers of Medical Device Regulation (MDR) products being supplied to the EU and US market

• Processing of deviations as well as CAPAs, Changes, Process Improvements

• Quality Incident Trend reports

• Implementation of GMP training and further development of employees' GMP knowledge

• Audit/Inspection SME incl audit preparation and different inspections, including mock audit MDR for

associates and auditor perspective to ensure compliance with regulatory requirements

• SME for all GMP and compliance related topics incl compliance expertise to the business, conducting Root Cause Analysis (RCA) to identify and address regulatory and compliance-related issues

• Review and update of the different Quality agreements between Anteis and Merz Aesthetics with collaboration of the different functions of different Merz affiliates

• Promote the safety and quality of medical devices under development

• Lead complex projects and quality initiatives and ensure inspection site readiness

• Promote a culture of continuous improvement and lean leadership

• Support of MDSAP project through the recruitment of consultants and establishment of an action plan with a predefined timeline to support the business

• Deputy for Global QA compliance director and others QA colleagues within the team

• Manage portfolio of assigned projects, support discipline and/or provide a service with a team of associates. Provide functional expertise in area of responsibility for medical devices and combination products

• Set up Quality Systems and related SOPs for the GDD TRD development and support to CMC team

• Driving optimization and standardization of different quality related processes with alignment with stakeholders

• Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance

• Works in close cooperation with the manufacturing for IMP release batches. Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.

• Manage quality problems and technical matters to ensure their compliance with applicable guidelines and regulations

• QA support and Management for combination products projects and early phases projects (phase 2 and phase 3 clinical for drop-trainer or BFS products)

• Release of medical devices/combination products for clinical studies and commercial use.

• Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients

• Support of vendor selection and qualification for development project activities.

• Third parties' services providers approval process, documentation management and monitoring: via QAA creation and maintenance of change control related

• Implementation of GMP training and further development of employees' GMP knowledge for Data Integrity and Root cause analysis, CAPA and Deviations

• Periodically report KPIs for QA Suppliers activity and participate to Participate to self-inspection

See CV for the rest ..