8 years of experience in Quality Assurance in pharmaceutical and biotechnology companies.Certified ISO 9001 Quality Management Systems Internal Auditor, involved in preparation of documentation and implementation of quality assurance standards - ISO 9001 and Good Distribution Practice in pharmaceutical wholesalers. Participation in Manufacturing Audits and Supplier Evaluation India and China. Participation in internal audits (ISO 13 854)7 years of experience as eDMS and eTMS administrator (MasterControl) and document controller. 3 years experience as Document Process Owner. Taking part or leading projects such as validation of system, testing, implementation, optimization.
Boehringer Ingelheim
View- Website:
- boehringer-ingelheim.com
- Employees:
- 39411
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Senior Validation Management SpecialistBoehringer Ingelheim Jul 2024 - PresentWrocław, Dolnośląskie, Poland
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Qa Manager Document ControlQiagen Business Services Wrocław Apr 2023 - Jul 2024Wrocław, Dolnośląskie, Poland -
Team Leader Qa Document ControlQiagen Business Services Wrocław Apr 2020 - Apr 2023Wrocław, Woj. Dolnośląskie, Polska
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Quality Assurance Document Control Specialist/ Subject Matter ExpertQiagen Business Services Wrocław Apr 2018 - Apr 2020Wrocław, Woj. Dolnośląskie, PolskaAdditional responsibilities (comparing to the previous position):- Implementation of new business units into Electronic Document Management System;- Conduct trainings for new employees
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Quality Assurance Document Control SpecialistQiagen Business Services Wrocław Dec 2016 - Apr 2018Responsibilities:- Check and monitor the formal compliance of procedures and operating instructions with the regulations, standards and procedures in force at the corporation (ISO 9001/13485, QSR 820, 21 CFR 820);- Maintain and administer controlled Documents and records with the Electronic Document Management System;- Formal Review of Documents;- Administer Training settings and data (Training Codes and Roles) for controlled documents;- Administer User settings in the Electronic Document Management System;
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InternshipElpharma Sc Oct 2015 - Aug 2016Kraków, Woj. Małopolskie, PolskaResponsibilities:- interpret and implement quality assurance standards (ISO 9001, GDP, GLP, GMP);- preparation of the documentation: procedures, instructions, flow charts diagrams, forms, reports;- work with operating staff to establish document management systems;- review the implementation and efficiency of quality and inspection systems;- participation in Manufacturing Audits and Supplier Evaluation (checking documentation such as: Risk Management Assessment, Audits, Product Review, Trainings, Personnel responsibilities, Hygiene, Change control, Complaint, Recalls and returns);
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Erasmus Summer ApprenticeshipInstitut D’Investigació Biomédica De Bellvitge (Idibell) Jul 2014 - Sep 2014Rejon Barcelona, HiszpaniaResponsibilities:- in vitro cell culture - human hepatocellular carcinoma cell lines;- Laboratory work: cell stimulation, fixation and immunostaining, fluorescent microscopy, siRNA transfection with liposomes, cell viability assay with cristal violet, isolation of proteins and total RNA from cultured cells, quantification, western blot, real time PCR;- record and interpret results;- use computers and perform mathematical calculations for the preparation of graphs;
Frequently Asked Questions about Anna Pluta
What company does Anna Pluta work for?
Anna Pluta works for Boehringer Ingelheim
What is Anna Pluta's role at the current company?
Anna Pluta's current role is QA.
Who are Anna Pluta's colleagues?
Anna Pluta's colleagues are Emilio Jesus Euan Mex, Claudia Hojnik-Machan, Kiky Maulana, Alisha Bahcic, Osnat Razon, Jasveen Kaur, 고대성.
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Anna Pluta
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Anna Pluta
Cyber Practice Leader | Client Executive | Broker Director | Specialist In Financial Lines Insurance At MarshWarsaw Metropolitan Area
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