Agnieszka Wujkowska

• Maintenance of the QMS and ensuring it is in line with current GMP/ GLP/ GCP and ISO17025 requirements and company procedures.
• Serving as the main point of contact for any quality related issues. 
• Providing proactive and regular communication of trends and performance metrics from the laboratory activities to ensure effective implementation of controls.
• Drafting, reviewing and approval of internal QMS documentation.
• Leading the CAPA process, coordinating root causes and corrective actions for both in-house and customer returns and complaints, with follow up checks to verify implementation.
• Managing the change control process to ensure that systems, processes and equipment remain fit for purpose at all times.
• Reviewing and approval of deviations and OOS investigations. 
• Reviewing method development and validation documentation. 
• Reviewing training files and monitoring training records and their effectiveness.
• Coordinating and management of clients and Regulatory inspections (MHRA, UKAS, FDA).
• Conducting internal audits to identify potential areas for improvement in the company's quality management systems
• Reviewing and approving suppliers.
• Producing and delivering specific and general training to all staff (e.g data integrity, good documentation practices, how to investigate quality issues, reduction of human error, GMP). 
• Identifying and implementing continuous improvement initiatives.
• Reviewing the equipment calibration and maintenance records.
• Archiving and Archive Management of the QMS documentation.
• Overseeing junior staff in QA department. 

Birkbeck College, University of London

2011-2012

Certificate of Higher Education in Life Sciences - Chemistry and Biology

Aleksander Gieysztor School of Humanities, Poland

2000-2003

Bachelor of Business Administration, Management and Operations

Professional courses:

RSSL – GMP in the Laboratory (2015)

RQA – Auditing (2015)

ECA – GMP (2016)

RQA – GLP for Study Directors, Principal Investigators and Study Staff (2016)

Essential negotiations Skills (2017)

RSSL- QP Analysis and Testing (2019)

Attended 2023 MHRA GMDP Symposia

Introduction to Management – October 2023.