Magdalena Zareba

- Co-ordination of the internal audits as required by the Internal Audit annual plan,
- Perform GMP and GMP Refresher training as required for new and existing personnel,
- Maintenance of QA systems, e.g., change control, deviation investigation and planned deviation systems e.g. Trackwise system,
- Preparation of cGMP documentation e.g. raw materials / product specification / SOP / APR within the QA Department,
- Maintenance of the computer based business systems, e.g. BRTS,
- Participation in continuous improvement projects e.g. Lead time reduction for batch time review,
- Control of QC status labelling of incoming materials and product,
- Member of the Self-Inspection Audit Team,
- Member of the GMP Housekeeping Team,
- QA Representative in relation to project support e.g. Metal to metal project,
- Quality Business Partner for Departments,
- working towards KPI improvements,
- open for Continuous Improvement Initiatives.

- Review of Batch Records,
- Pre - QP review of batches on a high level,
- Monitoring of Lead Times for Reviews,
- Intermediate Products release,
- Deviations system maintenance,
- Preparation of cGMP documentation e.g. raw materials / product specification / SOP / APR within the QA Department,
-Maintenance of the computer based business systems, e.g. BRTS,
-Participate in continuous improvement projects,
-Control of QC status labelling of incoming materials and product,
- Review of Regulatory Statements,
-Member of the Self-Inspection Audit Team,
-Member of the GMP Housekeeping Team,
-Participate in cross-functional training provided by QA,
-Control/storage of retain samples, including periodic retain inspection.

Production Technologist (September 2005 – February 2008)
This involves the following:
1. Working in different areas: Compression, Granulation, Blending, Packaging.
2. Producing product lots in strict compliance with cGMP and to the required Takeda quality standard.
3. Logging materials into and out of production as per MI requirements
4. Completing end of lot reconciliation and performing investigations where variances are out of specification
5. Assisting in validation of new equipment and products, carried out IQ, OQ and PQ on new equipment
6. Communicating internally with my supervisor and other team members and externally with other departments e.g. Warehouse, Engineering, QA, etc.
7. Cleaning: (Pharmaceutical, Comprehensive, Major, Minor), completing batch documentation (MI’s), area clearances, calibrating equipment and maintaining logbooks.
8. Performing stock controls using Élan XFP material tracking system and preparing stock reports for materials used in production.

September 2007 – February 2008 – Granulation & Blending Area,

- Working in accordance with existing SOP’s for area,
- Good knowledge of Granulation & Blending area,
- Strict compliance with all safety procedures,
- Performing changeovers, full assembly of granulation and blending equipment,
- Completing documentation strictly within GMP standards during every step of process,
- Good knowledge of sampling procedures,
- Working in a team with cooperation with Production Executives and Senior Technologists,

February 2006 – September2007 – Compression Area,

- Fully trained in Compression,
- Good knowledge of Compression process,
- Working in accordance with existing SOP’s for area,
- Strict compliance with all safety procedures,
- Performing changeovers, full assembly of compression equipment,
- Completing documentation strictly within GMP standards during every step of process,
- Good knowledge of sampling procedures,
- Working in a team with cooperation with Production Executives and Senior Technologists,
- Reporting all deviations during a process to Production Executive,

September 2005 – January 2006 – Acumen Recruitment Agency - Takeda Ireland LTD.,

VI and Packaging Department;

• Working within VI team in checking room,
• Performing checks and operations specified in DIRs issued during production stage,
• Manually packing blisters on blister lines,
• Visual inspection of product ( blisters and tablets) in accordance to existing SOP’s during all production process,
• Introducing materials for starting a process ( cartons, leaflets, tablets),
• Performing reconciliation at the end stage of a process,
• Good knowledge of sampling procedures within packaging area,
• Performing quality checks on product with time intervals outlined in SOP’s,
• Completing documentation strictly within GMP standards during every step of process,
• Working in a team with cooperation with Production Executives and Senior Technologists,
• Reporting all deviations during a process to Production Executive,
• Performing minor, major and comprehensive cleans in accordance with cleaning procedures outlined in SOP’s,