Urszula Piątek-Machaj Email and Phone Number
Urszula Piątek-Machaj is a Regulatory Affairs Product Specialist | MPharm at Theramex.
Theramex
View- Website:
- theramex.com
- Employees:
- 369
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Regulatory Affairs Product SpecialistTheramex Nov 2024 - PresentWarszawa, Woj. Mazowieckie, Polska -
Operational Quality Assurance SpecialistPolpharma Biologics Apr 2022 - Oct 2024Warszawa, Woj. Mazowieckie, Polska -
Operational Quality Assurance Junior SpecialistPolpharma Biologics Aug 2021 - Apr 2022-Preparation and review of GMP documents;-Assessment of both internal and external documentation;-Carrying out GMP visits in the Quality Control/Warehouse area;-Participation in inspections of pharmaceutical authorities and customeraudits, to the extent specified by the supervisor as well as in the internalaudits;-Participation in the change control, risk and deviation processes includingroot cause analysis;-Verification of the audit trail from computerized… Show more -Preparation and review of GMP documents;-Assessment of both internal and external documentation;-Carrying out GMP visits in the Quality Control/Warehouse area;-Participation in inspections of pharmaceutical authorities and customeraudits, to the extent specified by the supervisor as well as in the internalaudits;-Participation in the change control, risk and deviation processes includingroot cause analysis;-Verification of the audit trail from computerized systems to ensure dataintegrity;-Verification of the corrective and preventative actions in accordance withthe applicable procedures;-Assessment of certificates and other manufacturer documentation forcompliance against the specifications;-Data analysis to identify areas for improvement in the quality system;-Preparation of reports to communicate the results of quality activities;-Assessment of audit observations and implementation of appropriatecorrective actions;-Process materials release based on the supplier and warehousedocumentation compliance with specification;-Participation in Polpharma Biologics Warsaw projects in the scopedelegated by the line manager; Show less -
Quality Control Raw Materials Junior SpecialistPolpharma Biologics Oct 2020 - Aug 2021Warszawa, Woj. Mazowieckie, PolskaWork in pharmaceutical company in accordance with GxP regulations:-developing, reviewing and updating documentation (e.g. instructions, procedures);-employee’s training (preparing lists and programs, conducting trainings);-preparing documentation such as qualification reports and protocols, risk analysis and reports, data tables;-documenting deviations, change control, corrective actions- preventing actions (CAPA) in TrackWise/TrackWise Digital System;-preparing… Show more Work in pharmaceutical company in accordance with GxP regulations:-developing, reviewing and updating documentation (e.g. instructions, procedures);-employee’s training (preparing lists and programs, conducting trainings);-preparing documentation such as qualification reports and protocols, risk analysis and reports, data tables;-documenting deviations, change control, corrective actions- preventing actions (CAPA) in TrackWise/TrackWise Digital System;-preparing documentations and participating in internal audit;- monitoring environmental conditions (on-line, maintenance of failure log, preparing weekly reports, failures reporting);-cooperating with internal departments and external companies; -participating in internal meetings, conducting internal meetings;- placing orders and requisitions, participating in the complaint process;-deputizing for the coordinator in his absence, supervising work of the other employees of the team, supervising work of the employees of an external companies. Show less -
Registered PharmacistApteka Lekoteka Feb 2021 - Dec 2022Warszawa, Woj. Mazowieckie, PolskaPart-time job as Pharmacist to be with actual knowledge related to pharmacist rights and responsibilities and also to maintain my license to practice. -
Registered PharmacistGemini Polska Sp. Z O.O. Oct 2017 - Dec 2020Fulfilling professional duties of pharmacist:-making up prescriptions;-prescriptions control;-preparing and dispensing drugs;-producing special medications (ointments, creams, drops, mixtures, external/internal-use liquids, globules, suppositories, capsules, eye drops and ointments in aseptic conditions);-managment of pharmacy records;-controlling GIF decisions;-preparing work schedules;-replacing the pharmacy manager in his absence, overseeing the of other… Show more Fulfilling professional duties of pharmacist:-making up prescriptions;-prescriptions control;-preparing and dispensing drugs;-producing special medications (ointments, creams, drops, mixtures, external/internal-use liquids, globules, suppositories, capsules, eye drops and ointments in aseptic conditions);-managment of pharmacy records;-controlling GIF decisions;-preparing work schedules;-replacing the pharmacy manager in his absence, overseeing the of other pharmacy workers. Show less -
Registered PharmacistApteka Wawa Sp. Z.O.O Apr 2016 - Oct 2017Warszawa, Woj. Mazowieckie, Polska
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Pharmacist - TraineeApteka Wawa Sp. Z.O.O Oct 2015 - Mar 2016Warszawa, Woj. Mazowieckie, Polska
Urszula Piątek-Machaj Education Details
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Pharmacy
Frequently Asked Questions about Urszula Piątek-Machaj
What company does Urszula Piątek-Machaj work for?
Urszula Piątek-Machaj works for Theramex
What is Urszula Piątek-Machaj's role at the current company?
Urszula Piątek-Machaj's current role is Regulatory Affairs Product Specialist | MPharm.
What schools did Urszula Piątek-Machaj attend?
Urszula Piątek-Machaj attended Uniwersytet Jagielloński W Krakowie.
Who are Urszula Piątek-Machaj's colleagues?
Urszula Piątek-Machaj's colleagues are Isabelle Barros, Gareth Amer, Vonn De La Torre, Céline Le Discot, Federica Cuccato, Valdely Valadão Junior, Ana Carla Reis.
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