Eva Troja Ph.D.

Technical Director

About

Results-driven professional with over 17 years of experience in quality control, microbial & aseptic techniques, and laboratory administration. Proven success in analysing in-process and final bulk product samples according to Standard Operating Procedures and Test Methods, creating & implementing testing plans, and engaging in calibration of laboratory equipment. Adept at managing routine release control testing. Accustomed to provide general lab support including laboratory housekeeping, equipment maintenance, inventory of supplies, and laboratory cleaning. Recognized for reviewing written procedures and advising team members on quality matters. Proficient in BET, Bioburden testing, Sterility testing, aseptic techniques, analytical microbiology, and media fill.

Country

Albania

City

Tirana

Industry

Pharmaceuticals

Skill

Clinical Study Design, Corrective and Preventive Action (CAPA), Validation (Drug Manufacture), GMP, SOP, Pharmaceutics, Pharmaceutical Industry, HPLC, Quality Control, GLP, Regulatory Affairs, Laboratory, Pharmacology, Microbiology, Pharmaceutical Microbiology, Pharmacovigilance, Cleaning Validation, Regulatory Submissions, Standard Operating Procedure (SOP), Pharmacists

Experience

Technical Director

Ilumina drug distributor

2022-4 - Present · 4 yrs 6 mos

Microbiologist/Pharmacist

Profarma Sh.a

2007-11 - Present · 18 yrs 11 mos

Pharmacist at Microbiology laboratory

Perform testing of raw materials and intermediate & final products as per pharmacopoeias USP/BP/EP/JP. Carry out sampling of routine utilities, including compressed air, nitrogen, WFI/DIW, and clean steam. Perform Bioburden, Endotoxin, Total Plate Count, Biological Indicator testing, and Plate Reading. Ensure materials suitability for usage by analysing material specifications and performing material qualifications. Determine root cause of OOS result and take appropriate corrective/preventative action by investigating microbiology related deviations, (NCEs), and OOS while implementing appropriate CAPAs. Operate Sterility Isolator and perform routine maintenance and testing to ensure absence of viable contaminating microorganisms in product. Manage quality control through sample coordination, peer review, lab equipment maintenance, QC document management, QC inventory control, and reconciliation of sample requests/documents. Maintain and monitor laboratory equipment for temperature and humidity to avoid any future distraction over validity and reliability of test results. Identify loopholes and recommend viable solution for smooth running of operations. Contribute in scientific initiatives.

Pharmacist

Profarma Sh.a

2007-11 - 2008

Quality Control Department

QC technician - API and excipients testing according to USP, BP, Eur.Ph

Technical Director

Galaxy drug distributor

2015-6 - 2022-4 · 6 yrs 11 mos

Tirana, Albania

Managed and maintained regional marketing of drug product. Supervised technical development strategy and implementation. Directed and monitored technical issue throughout approval process. Developed robust plans to define and implement technical development strategy for drug product.

Education

University of Tirana

Bioequivalence study

2012-9 - 2021-4 · 8 yrs 8 mos

Thesis: “Pharmacokinetic studies in assessing therapeutic equivalence of locally produced metformin compared with Glucophage and Siofor” Mentor: Prof. Asc Leonard Deda Overall result: 98/100