Marta K. Email & Phone Number

Wroclaw, Lower Silesian District, Poland

Wroclaw, Lower Silesian District, Poland

Dublin, Ireland

- Provide active support and participation in managing the Pharmaceutical Quality System - Measure and promote continuous quality improvements in supplier performance Quality event management e.g. complaints handling, deviations and CAPA management - To provide support for change management - Prepare and maintain QA documentation and reports - Management of customer and product technical issues - Prepare and assist CMOs for regulatory audits - Participate in supplier audits - Take part in new products and new CMOs due diligence, technology transfer and assist in regulatory applications - Effectively liaise with management and other team members - Promote quality assurance in other areas of the supply chain to enhance quality of our products.

Bray

- Perform the Quality Review of Batch Records- Support the site Quality Management systems including the Deviation and CAPA management systems, Change Control system, Internal Auditing programme, GMP Training, Customer Complaints and the Vendor Management processes.- Prepare and review cGMP documentation, Annual Product Reviews, Standard Operating Procedures etc- Assist in the investigation into non-conformances, participate in Root Cause Analyses and carry out the Quality Review of non-conformances- Participate in Continuous Improvement projects- Conduct Customer Complaint Investigations- Perform Internal & External Audits- Deliver Quality Training modules to various departments eg AQL Training, GMP Refresher, Garbing Induction etc- environmental monitoring

Bray Co.Wicklow

- Help to maintain a continuous state of validation (IQ/OQ/PQ) of equipment and utility systems.- Help to maintain a continuous state of process validation and cleaning validation.- Participation in cross functional project teams as the validation representative.- Preparation and compliance with validation policies and SOPs.- Preparation, review and execute of validation master plans, protocols and reports.- To report and update the Quality Department in Validation activities across the plant as and when required.- Ensuring compliance with current industry regulations and guidelines relating to validation.- Review of all change controls assessing impact on validation.

Bray, Co. Wicklow

join ‘response management’ teams for major processrelated incidents; use statistical software packages in the indentificationand reporting of shifts, signals and trends in critical process parametersand product quality attributes; prepare Manufacturing Instructions andStandard Operating Procedures; execute process improvement projectsand deviation investigations in accordance with pre-approved projectcharters, test plans and schedule; train existing and new production staffresulting from the introduction by PTD of new products and/or processes

Bray Co. Wicklow

practical application of Lean Tools; SMED, RCA, Kaizen, FMEA & 5S; manufacture of product in strict compliance with procedures and batch manufacturing records (BMR’s), incorporating cGMP and safety procedures; accurate and timely completion of all relevant checks as per Electronic Batch Records and ancillary paper documents; generation of relevant Standard Operating Procedures and Manufacturing Batch Records as required.

Dublin, Ireland

general production duties; fulfilment of work orders; complete relevant production documentation

Dublin, Ireland

co-operate with account and sales departments; preparation of shift rosters for kitchen staff; ensure that adequate stock levels of food products for daily running of the restaurant is maintained at all times

Dublin, Ireland

general production duties; fulfilment of work orders; complete relevant production documentation

Wrocław, Poland

customer service; register and distribute mail; superviseproper circulation of documents and organisational information in office A.F.O.

Master In Pharmaceutical Quality Assurance And Regulations

Bachelor'S Degree, Public Administration With Major In Labour Law And Labour Protection

Statistical Process Control

Six Sigma Yellow Belt