Qa Validation Specialists Lead
Current๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ ๐๐ฉ๐๐๐ข๐๐ฅ๐ข๐ฌ๐ญ ๐ฐ๐ข๐ญ๐ก ๐๐ฑ๐ญ๐๐ง๐ฌ๐ข๐ฏ๐ ๐๐ฑ๐ฉ๐๐ซ๐ข๐๐ง๐๐ ๐ข๐ง ๐๐๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐, ๐ช๐ฎ๐๐ฅ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง, ๐ฏ๐๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง, ๐๐ง๐ ๐๐จ๐ง๐ญ๐ข๐ง๐ฎ๐จ๐ฎ๐ฌ ๐ข๐ฆ๐ฉ๐ซ๐จ๐ฏ๐๐ฆ๐๐ง๐ญ, ๐๐๐ฅ๐ข๐ฏ๐๐ซ๐ข๐ง๐ ๐ข๐ฆ๐ฉ๐๐๐ญ๐๐ฎ๐ฅ ๐ซ๐๐ฌ๐ฎ๐ฅ๐ญ๐ฌ ๐๐๐ซ๐จ๐ฌ๐ฌ ๐๐ข๐ฏ๐๐ซ๐ฌ๐ ๐ฉ๐ซ๐จ๐ฃ๐๐๐ญ๐ฌ:โพ ๐๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ ๐๐ซ๐๐ง๐ฌ๐๐๐ซ: Led GMP compliance efforts for three technology transfer projects over two years, ensuring effectiveโฆ Show more ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ ๐๐ฉ๐๐๐ข๐๐ฅ๐ข๐ฌ๐ญ ๐ฐ๐ข๐ญ๐ก ๐๐ฑ๐ญ๐๐ง๐ฌ๐ข๐ฏ๐ ๐๐ฑ๐ฉ๐๐ซ๐ข๐๐ง๐๐ ๐ข๐ง ๐๐๐ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐, ๐ช๐ฎ๐๐ฅ๐ข๐๐ข๐๐๐ญ๐ข๐จ๐ง, ๐ฏ๐๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง, ๐๐ง๐ ๐๐จ๐ง๐ญ๐ข๐ง๐ฎ๐จ๐ฎ๐ฌ ๐ข๐ฆ๐ฉ๐ซ๐จ๐ฏ๐๐ฆ๐๐ง๐ญ, ๐๐๐ฅ๐ข๐ฏ๐๐ซ๐ข๐ง๐ ๐ข๐ฆ๐ฉ๐๐๐ญ๐๐ฎ๐ฅ ๐ซ๐๐ฌ๐ฎ๐ฅ๐ญ๐ฌ ๐๐๐ซ๐จ๐ฌ๐ฌ ๐๐ข๐ฏ๐๐ซ๐ฌ๐ ๐ฉ๐ซ๐จ๐ฃ๐๐๐ญ๐ฌ:โพ ๐๐๐๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ ๐๐ซ๐๐ง๐ฌ๐๐๐ซ: Led GMP compliance efforts for three technology transfer projects over two years, ensuring effective qualification and validation processes for regulatory approvals and market readiness.โพ ๐๐ข๐ญ๐ ๐๐๐ฅ๐ข๐๐๐ญ๐ข๐จ๐ง ๐๐ซ๐จ๐ฃ๐๐๐ญ๐ฌ: Oversaw 15+ equipment qualifications and 10+ process and packaging validations across liquids and solid dose product lines over three years, maintaining compliance with no failed client or regulatory audits.โพ ๐๐ซ๐๐ข๐ง๐ข๐ง๐ ๐๐ง๐ ๐๐๐๐ฆ ๐๐๐ฏ๐๐ฅ๐จ๐ฉ๐ฆ๐๐ง๐ญ: Delivered RCA and non-conformance management training to 60+ staff, enhancing proficiency, fostering accountability, and achieving compliance with the 30-day closure requirement.โพ ๐๐ฎ๐ฉ๐ฉ๐ฅ๐ข๐๐ซ ๐๐ง๐ ๐๐ฎ๐๐ข๐ญ ๐๐๐ง๐๐ ๐๐ฆ๐๐ง๐ญ: Managed quality systems for suppliers, materials, 3PL warehouses, and contracted services, completing 7 local audits and 1 international audit, securing API manufacturer qualification and a key milestone toward product market launch.โพ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐จ๐ฆ๐ฉ๐ฅ๐ข๐๐ง๐๐: Partnered with the engineering team under the Global Validation Manager to reduce overdue periodic review tasks by 39%, strengthening FDA audit readiness. Show less