Experience

Medfiles

• Finland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA Director, QP

  • Jan 2018 - Present

  Responsibility of general quality and GxP works at Medfiles. Good knowledge in EU GMP (Good Manufacturing Practice), GCP (Good Clinical Practise) and Quality Control/Assurance procedures. Experience in deviation handling, out of specification (OOX) and corrective and preventive actions (CAPA) procedures, change control, risk management, validation procedures and GxP trainings (including QPs). Consultation concerning EU GMP. Writing of SOPs and company policies. Experience in audits (conduct internal and subcontract audits, participating several authorities’ audits). Acting as QP of IMPs and responsible director (GMP).

• QA Manager

  • Jun 2008 - Dec 2017

  Responsibility of GxP works.Good knowledge in EU GMP (Good Manufacturing Practice), GCP (Good Clinical Practise) and Quality Control/Assurance procedures. Experience in deviation handling, out of specification (OOS) and corrective and preventive actions (CAPA) procedures, change control, risk management, validation procedures and GxP trainings (including QPs). Consultation concerning EU GMP. Writing of SOPs and company policies. Experience in audits (conduct internal and subcontract audits, participating several authorities’ audits).

• CRA

  • Jan 2001 - May 2010

  Experience in monitoring clinical studies (e.g. cardiovascular disorders, CNS / nervous system, endocrinal disorders, oncology, food and vaccines studies).

• Supervisor of labeling and packaging unit (GMP)

  • Jan 2001 - May 2005

  Supervised of IMP´s package and labeling. Experience as a supervisor at Oy Medfiles Ltd, Finland at the packaging and labeling unit of the investigational products. Experience in several different projects; packaging, labelling, label design, code envelopes preparing and consultation concerning investigational products. Helping QP with his duties.