Ágnes Posta, Pharm.D.
Qualified Person
Zalaegerszeg
Summary
Qualified Person for six years at a CDMO: Releasing for commercial use and for clinical trials. Release of human and veterinary medicines, medical devices. Preparing of QP declarations, TSE&BSE statements. Supervision of investigations, deviations, complaints, OOSs. Liable for GMP compliance, participation in inspections and audits. Leading of customer audits.
Pharm. technologist: over thirteen years of experience at a multinational company and at a medium-sized CDMO. Experienced in NP introductions, process validation and equipment qualification, improvement of product robustness. Participation in investigation of deviations, complaints.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
13
13
years of professional experience
8
8
years of post-secondary education
2
2
Certifications
2
2
Languages
Work History
Qualified Person
Pernix Pharma Pharmaceutical Ltd
02.2019 - Current
- Finished product release (for commercial and clinical trials)
- Performing audits and self-inspections
- Supporting line QA
- Liable for Compliance (registration dossier vs manufacturing documentation, specifications, GMP compliance)
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Managed time efficiently in order to complete all tasks within deadlines.
Head of R&D
Pernix Pharma Pharmaceutical Ltd
08.2019 - Current
- Leading of R&D division, development of new products (solid, semi-solid and liquid), Improvement of routine manufacturing and efficacy.
- Regulatory support
- Project management of NPIs
- Excellent communication skills, both verbal and written.
- Self-motivated, with a strong sense of personal responsibility.
Head of QA (interim)
Pernix Pharma Pharmaceutical Ltd
10.2022 - 01.2023
- Leading of QA and QC, handling of complaints, deviations, OOSs, change controls.
- Preparing Quality agreements.
- Performing audits.
Pharma technologist
TEVA Pharmaceutical Ltd
08.2012 - 01.2019
- Prime roles were process validation, development (solid products), deviation and investigations, scaleups from R&D scale to commercial, tech transfers, regulatory support, complaint investigations, design of stability tests.
Education
Master of Science - Pharmacy
Medical University of Debrecen
09.2007 - 06.2012
Pharma technology specialist -
Medical University of Szeged
09.2013 - 11.2016
Skills
- Driving license
- Microsoft office
- Team management
- Lean management
- Teamwork and collaboration
- Problem-solving
- Time management
- Calm under pressure
Certification
GMP auditor, Wil-Zone Consulting Ltd., 03/01/24
Professional Development
- Continuous training, up to date with legislation as a member of the MAGYOSZ Quality Assurance Committee
- Membership of Medicine for Europe working group regarding TiO2
Timeline
Head of QA (interim)
Pernix Pharma Pharmaceutical Ltd
10.2022 - 01.2023
Head of R&D
Pernix Pharma Pharmaceutical Ltd
08.2019 - Current
Qualified Person
Pernix Pharma Pharmaceutical Ltd
02.2019 - Current
Pharma technology specialist -
Medical University of Szeged
09.2013 - 11.2016
Pharma technologist
TEVA Pharmaceutical Ltd
08.2012 - 01.2019
Master of Science - Pharmacy
Medical University of Debrecen
09.2007 - 06.2012
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