Kamila Sonczyk Email & Phone Number

Szczecin, Woj. Zachodniopomorskie, Polska

-Development and improvement of global QMS-Development of inputs to Management Review-Prepare gap analysis of the new requirements -Conduct internal audits -Conduct QMS training -Participation and support of the departments during audits and inspections -Help other departments to understand regulatory requirements-CAPA-change control

Responsibilities-Register products for companies within Diagnostics Instruments in prioritized countries;-Ensure country specific details are updated and necessary work instructions are created/updated;-Communicate design changes to relevant countries;-Ensure that RA Intelligence is collected and listed in newsletter & action log;-Ensure that data in the Regulatory Affairs System always are updated;-Provide support during labelling and IFU creation/modification;-Support the organization in relation to Regulatory Affairs related issues;-Cooperate with notifying body and quality during remote audits;- Secure the interest of the Brand within DGS Diagnostics Regulatory Affairs;- Ensure communication towards the Brand Key Account;- Ensure knowledge of brand strategic priorities (countries / product segments / products) and their withdrawals;-Within Diagnostics, ensure the technical documentations are proactively drawn up and kept up-to-date.

Szczecin, Woj. Zachodniopomorskie, Polska

Responsibilities:-participation in QMS planning,-development of gap assesment for the new regulations/standards-preparation for third party audits,-running audits for certifying body (compliance with IS0 13485, US FDA 21 CFR part 820, RDC, TGA, MDR 2017/745) and for the clients,-communication with the notified body,-development of the management review report,-development of product annual review,-preparation of improvement plans and quality plans,-supervision over changes in the QMS documentation,- implementation of 14644 into QMS (clean-room)-supervision over CAPA,-supervision over complaints, - participation in the QMS change management,-development/updates of technical file according to MDR 2017/745 (risk management, usability, biological evaluation, declaration of conformity etc.),- verification of clinical evaluation,-development/updates of quality agreements,- verification of design documentation,- internal auditor,-verification of internal audit reports,- training of employees, internal auditors in the quality management system,- supervision over RA,- postmarketing activites (PSUR, PMS).

Szczecin, Woj. Zachodniopomorskie, Polska

Responsibilities:-participation in QMS planning,-development of gap assesment for the new regulations/standards-preparation for third party audits,-running audits for certifying body (compliance with IS0 13485:2016, US FDA 21 CFR part 820, RDC, MDR 2017/745) and for the clients,-communication with the notified body,-development of the management review report,-development of product annual review,-preparation of improvement plans and quality plans,-supervision over changes in the QMS documentation,-supervision over CAPA,-supervision over complaints, - participation in the QMS change management,-development/updates of technical file according to MDR 2017/745 (risk management, usability, biological evaluation, declaration of conformity etc.),- verification of clinical evaluation,-development/updates of quality agreements,- verification of design documentation,- internal auditor,-verification of internal audit reports,- training of employees, internal auditors in the quality management system,- supervision over RA,- postmarketing activites (PSUR, PMS).

Szczecin, West Pomeranian District, Poland

Responsibilities-implementation of EU MDR 2017/745 regulation into QMS,-participation in QMS planning,-development of gap assesment for the new regulations/standards-preparation for third party audits,-running audits for certifying body (compliance with IS0 13485:2016, US FDA CFR part 820) and for the clients,-development of the management review report,-supervision over changes in the QMS documentation,- participation in the change management,-implementaion of changes into QMS documentation,-communication with the notified body,-development/updates of technical file,-development/updates of risk management documentation,-development/updates of quality agreements-supervision over CAPA,- internal auditor-verification of internal audit reports,- training of employees, internal auditors in the quality management system,- carrying out the product annual review, -preparation of improvement plans and quality plans

Szczecin, West Pomeranian District, Poland

QMS-preparation GMP requirements for China/Europe-preparation GMP audit questions for QMS processes-preparation MDR requirements-preparation basic information regarding MDSAP -handling CAPA-supervision over supplier/service provider assesmentQCoutgoing inspection of Medical devices

West Pomeranian District, Police County, Poland

1.Very experienced in certification of medicinal batches (medicinal oxygen) and releasing medicinal products for sale (medicinal oxygen)2.Active participation in validation tests and in verifying and approving validation reports and protocols concerning manufacturing of medicinal oxygen3.Good knowledge of GMP 4.Responsible for trend analysis of medicinal oxygen (Shewhart control chart) and managing out of trend result, out of specification results, deviations, nonconforming products, products claims, product recall, responsible for approving the suppliers, taking part in change control process,5. Ensuring that all necessary controls/audits have been carried out , all necessary changes/deviation have been authorised, that the required documentation have been developed/approved,6.Responsible for verifying the documentation concerning medicinal product (documentation of pharmaceutical quality system),7.Experienced in preparing Annual Product Review (medicinal oxygen) in accordance with GMP regulation8.supervisor of small team in the laboratoryvery experienced in analysis of medicinal, technical, food gases9.Extensive knowledge of gas chromatography (TCD,ADD,DID, FID detectors)10.Responsible for ensuring compliance with internal standards and policies11.Active participation in ISO 9001 audits, corporate audits, GMP audits, GMP inspections carried by Pharmaceutical Inspectorate (Representative of Quality Control Department during ISO 9001 audits)

Szczecin, West Pomeranian District, Poland