Irina

Operational work on the company's quality system and QA SOPs. Handling of complaints and GDP deviations. Handling of QA statements regarding deliveries.

Quality Assurance Manager / Deputy RP at Unimedic Pharma AB (2024-01 – Present)

• Operational work on the company's quality system and QA SOPs.
• Handling of complaints and GDP deviations.
• Handling of QA statements regarding deliveries.
• Delivery of onboarding and continued training in GDP/QA.
• Review and approval of CAPAs, change controls, risk analyses and PQRs, and management of recalls.
• Act as back-up to the Responsible Person (RP) for the company's wholesale distribution authorisation in accordance with delegation.
• Decide on the final disposition of returned, rejected, recalled or falsified products, in accordance with agreements.
• Approve any return of returns or quarantined products to saleable stock during the absence of the Responsible Person (RP).
• Take decisions in the capacity of back-up to the Responsible Person for the wholesale distribution authorisation and QA staff, in accordance with applicable SOPs.

Responsible Person / Commercial Quality Head of Iceland at Teva Pharmaceuticals (2022-10 – 2023-01)

Responsible as Commercial Quality Head of the country, in alignment with the business unit, to ensure products are efficiently distributed into the country by meeting Teva, regional and local standards and customer needs. Managed the Commercial Quality unit team and acted as the Commercial Quality business partner of the General Manager, or its delegate.

• Led periodic Local Quality Management meetings with commercial unit management and supporting functions (Supply Chain, Regulatory Affairs, Pharmacovigilance).
• Took decisions on final disposition related to product quality (returns, recalls, rejected or falsified products).
• Handling of deviations, CAPAs, change controls, recalls and other quality-related tasks.

Senior Pharmacist Consultant at Kronans Apotek AB (2018-09 – Present)

Medicines management, administration, pharmacovigilance, error handling, risk analysis, quality and advisory work.

Quality Executive Sweden at Janssen-Cilag AB, Solna (2021-06 – 2021-11)

Responsible for oversight of compliance with GDP requirements for Janssen Nordics, with special focus on Sweden and oversight for Iceland. Responsible for compliance with the elements of the company Quality Policy and QMS.

• Handling of deviations, CAPAs, change controls, recalls and other quality-related tasks.
• Took decisions on final disposition related to product quality (returns, recalls, rejected or falsified products).

Responsible Person / Head of Quality Assurance at Dagab AB / Axfood AB (2020-04 – 2021-04)

Maintained Dagab's quality system governing the handling of medicines, ensuring GDP requirements were met. Responsible for wholesale trade permits, contacts with authorities, and internal and external inspections.

Owner / Consultant, Licensed Pharmacist at ISEB Pharma Consulting AB (2018-11 – 2020-04)

Consulting services ensuring the safe handling and use of medicines in health and care, pharmacies and health services — services that simplify, relieve and streamline operations.

Assistant Pharmacy Manager / Pharmacist Responsible for Pharmaceuticals at Apoteksgruppen AB (2015-08 – 2018-11)

Responsible for quality and safety issues in pharmacies, finances and personnel, budget follow-up, and the pharmacy's ISO 9001 certification, together with category work and campaigns.

Licensed Pharmacist / Supervisor for Pharmacy Students at Apotek Hjärtat (2014-12 – 2015-07)

Quality Manager at Lloyds Apotek (2013-12 – 2014-12)

Responsible for quality and safety issues, ensuring pharmacies met requirements for self-inspection.

Pharmacy Manager (New Establishment) at Kronans Droghandel (2011-07 – 2012-01)

Medicines management, administration, error handling, risk analysis, quality and advisory work, with finance and personnel responsibilities.

Ambulatory Pharmacist at Apoteket Hjärtat (2011-01 – 2011-07)

Drug management, managerial tasks, medication reviews and additional-sales matters.

Licensed Pharmacist at Apoteket AB (2002-09 – 2010-12)

Manufacturing pharmacist at Södersjukhuset (2008-05 – 2010-12). Personal pharmacist; deviation and error-handling reporting; documentation of drug-related problems.

• Manufacture of cytostatics, handling of prescriptions, and collaboration with doctors and department heads on improvement measures, quality review and final control.

Pharmacist Trainee at Apoteket AB (2001-09 – 2002-01)

MSc in Pharmacy