Kırklareli, Türkiye
As a pharmaceutical professional with over 14 years of specialized experience, I currently serve as the Microbiology Validation and Qualification Supervisor at Polifarma Pharmaceuticals. I possess deep expertise in microbiological testing, environmental monitoring, aseptic processing, and regulatory compliance. Together with my team, I focus on optimizing laboratory processes and ensuring continuous compliance with GMP, ISO, and other global regulatory standards. Driven by a passion for continuous improvement and an unwavering commitment to quality, I dedicatedly contribute to achieving organizational goals and driving operational excellence.
Experienced Quality Control Microbiology Coordinator with expertise in microbiological testing, environmental monitoring, aseptic processing, and regulatory compliance in the pharmaceutical industry. Strong leadership in managing microbiology teams, optimizing lab workflows, and ensuring compliance with EU GMP, ISO,EP, USP, and cGMP/GLP standards. Key Responsibilities & Expertise: • Leading the microbiology laboratory team to ensure efficient testing of water, raw materials, in-process materials, intermediates, and final products (including endotoxin, sterility, microbiological assay and bioburden testing). • Managing environmental monitoring programs for cleanrooms and aseptic manufacturing areas in compliance with ISO and EU GMP standards. • Conducting aseptic process simulations (media fills), bacterial endotoxin testing, TOC analysis, microbial monitoring, Gram staining, sub-culturing, plating, and membrane filtration per USP and regulatory guidelines. • Overseeing sterility testing and microbial identification using MALDI-TOF and Vitek 2. • Developing and training the microbiology team, fostering a culture of compliance and continuous improvement. • Managing laboratory resources, stock control, and procurement to ensure uninterrupted operations. • Conducting risk assessments, deviation investigations, CAPA processes, and OOS/OOT evaluations with cross-functional teams. • Ensuring compliance with GMP and GLP standards through effective SOPs, validation protocols, and documentation. • Representing microbiology in regulatory inspections and internal/external audits. • Collaborating with Quality Assurance, Manufacturing, and R&D to facilitate timely product release and process improvements. A results-driven leader with strong problem-solving and decision-making skills, committed to ensuring high-quality and regulatory-compliant microbiology operations that support pharmaceutical manufacturing excellence.