Independent GMP & Technical Consultant
I help sterile pharmaceutical manufacturers get from where they are to EU GMP.
Remote and on site · Türkiye, Europe, MENA, Central Asia
Working languages English and Turkish
Twenty-one years in pharmaceutical manufacturing and quality assurance, seventeen of them on the production floor: solid dose, semi-solids, syrups, sterile liquids and ointments; six years of freeze-dried cytotoxics and antibiotics; five years of penicillin powder filling in segregated sterile suites. At peak, 45 products and 2.1 million boxes a month.
As Senior QA Manager at a veterinary sterile facility I built the quality system from zero — ICH Q10 structure, full GMP documentation, media fills, cleaning and process validation — and led the regulatory inspections through which the plant received its GMP certificates. Earlier: greenfield plant set-up, GDP warehouse qualification, technology transfer with foreign engineering teams.
Independent since 2016, including the technical feasibility study for a large volume parenteral plant — 500 mL polypropylene bag serum, 30 million bags a year.
I am also the developer of a 28-module pharmaceutical eQMS built against ICH Q10, EU GMP, PIC/S and 21 CFR Part 11. When I assess your computerised systems, I have built one — not only used one.
No charge. Enough to establish whether there is a problem worth paying to define.
Fixed scope, fixed price. Documentation review, facility walkthrough, operator-level interviews and record sampling. Findings classified by patient risk.
Phased remediation plan costed in money and months, with an honest answer on whether your target inspection date is achievable.
No affiliation with any equipment supplier, engineering contractor or turnkey EPC provider. No commission on anything you buy. Mutual NDA before any site access.