Burlacu Alexandra

Experience

• 

  Vel Pitar

  Aug 2011 - Dec 2014

  Shift leader

  • Team and Product Management: Coordinated shift scheduling (25-28 team members), orders implementation and effectively managed team assignments, execution, raw material inventory and documentation to optimize resources.• Reporting: Liaised with the head of production to align with operational requirements.• Quality control: Maintained a strong focus on quality control throughout all processes.• Performance review: Conducted regular performance evaluations of operators, recommending merit-based bonuses.• Cost optimizations: Lean 6 Sigma methodologies to enhance productivity and reduce waste. Show less

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  Zentiva

  Dec 2014 - Jan 2021

  • 𝐂𝐨𝐨𝐫𝐝𝐢𝐧𝐚𝐭𝐞𝐝 𝐞𝐱𝐩𝐞𝐫𝐢𝐦𝐞𝐧𝐭𝐚𝐥 𝐚𝐧𝐝 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐢𝐚𝐥 𝐯𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐛𝐚𝐭𝐜𝐡𝐞𝐬, overseeing technical processes to meet production and regulatory standards.• 𝐋𝐞𝐝 𝐜𝐡𝐚𝐧𝐠𝐞 𝐜𝐨𝐧𝐭𝐫𝐨𝐥 𝐩𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬 𝐚𝐧𝐝 𝐬𝐭𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐬𝐭𝐮𝐝𝐢𝐞𝐬, ensuring consistent quality and compliance of pharmaceutical products across the portfolio.• 𝐒𝐮𝐩𝐩𝐨𝐫𝐭𝐞𝐝 𝐜𝐫𝐨𝐬𝐬-𝐝𝐞𝐩𝐚𝐫𝐭𝐦𝐞𝐧𝐭𝐚𝐥 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧, aligning production processes with R&D, QA, and packaging teams to improve workflows and meet deadlines.• 𝐄𝐯𝐚𝐥𝐮𝐚𝐭𝐞𝐝 𝐚𝐧𝐝 𝐪𝐮𝐚𝐥𝐢𝐟𝐢𝐞𝐝 𝐧𝐞𝐰 𝐬𝐮𝐩𝐩𝐥𝐢𝐞𝐫𝐬 𝐟𝐨𝐫 𝐀𝐜𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐈𝐧𝐠𝐫𝐞𝐝𝐢𝐞𝐧𝐭𝐬 (𝐀𝐏𝐈𝐬) and packaging materials, ensuring cost efficiency and compliance.• 𝐑𝐞𝐬𝐩𝐨𝐧𝐝𝐞𝐝 𝐭𝐨 𝐚𝐮𝐭𝐡𝐨𝐫𝐢𝐭𝐲 𝐢𝐧𝐪𝐮𝐢𝐫𝐢𝐞𝐬 preparing detailed documentation and implementing solutions for identified deficiencies, ensuring timely approvals. Show less • 𝐃𝐢𝐫𝐞𝐜𝐭𝐞𝐝 𝐚𝐧𝐝 𝐦𝐨𝐭𝐢𝐯𝐚𝐭𝐞𝐝 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐭𝐞𝐚𝐦𝐬 to achieve targets, ensuring seamless operations and maintaining high-quality standards across all production stages.• 𝐑𝐞𝐯𝐢𝐞𝐰𝐞𝐝 𝐚𝐧𝐝 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐰𝐨𝐫𝐤 𝐢𝐧𝐬𝐭𝐫𝐮𝐜𝐭𝐢𝐨𝐧𝐬, 𝐩𝐫𝐨𝐜𝐞𝐝𝐮𝐫𝐞𝐬 𝐚𝐧𝐝 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 to meet internal audit requirements and ensure regulatory compliance during inspections.• 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐞𝐝 𝐩𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐰𝐨𝐫𝐤𝐟𝐥𝐨𝐰𝐬 to identify process deviations, performing analyses and implementing corrective actions to maintain consistent product quality.• 𝐀𝐩𝐩𝐥𝐢𝐞𝐝 𝐋𝐞𝐚𝐧 𝐒𝐢𝐱 𝐒𝐢𝐠𝐦𝐚 𝐩𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬 to streamline production processes, reduce waste, enhance efficiency, and drive continuous improvement initiatives across the team.• 𝐂𝐨𝐧𝐝𝐮𝐜𝐭𝐞𝐝 𝐭𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐩𝐫𝐨𝐠𝐫𝐚𝐦𝐬 𝐟𝐨𝐫 𝐧𝐞𝐰 𝐨𝐩𝐞𝐫𝐚𝐭𝐨𝐫𝐬, ensuring they developed necessary skills to work independently while sustaining production excellence. Show less

  • Manufacturing Technology Specialist

    May 2019 - Jan 2021

  • Production Shift Leader - Solid Dosage Forms

    Dec 2014 - May 2019
• 

  Sware

  Feb 2021 - Nov 2024

  Computer System Assurance/ Computer System Validation Project Manager

  • 𝐒𝐮𝐩𝐞𝐫𝐯𝐢𝐬𝐞𝐝 𝐚𝐧𝐝 𝐜𝐨𝐨𝐫𝐝𝐢𝐧𝐚𝐭𝐞𝐝 𝐜𝐫𝐨𝐬𝐬-𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐒𝐀 𝐭𝐞𝐚𝐦𝐬, consultants, and collaborators to ensure project deliverables aligned with objectives.• 𝐌𝐚𝐢𝐧𝐭𝐚𝐢𝐧𝐞𝐝 𝐬𝐭𝐫𝐨𝐧𝐠 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐰𝐢𝐭𝐡 𝐬𝐭𝐚𝐤𝐞𝐡𝐨𝐥𝐝𝐞𝐫𝐬, ensuring clarity in project scope, timelines and deliverables, configuring software according to the requirements, while resolving conflicts effectively.• 𝐎𝐫𝐠𝐚𝐧𝐢𝐳𝐞𝐝 𝐚𝐧𝐝 𝐥𝐞𝐝 𝐝𝐚𝐢𝐥𝐲 𝐦𝐞𝐞𝐭𝐢𝐧𝐠𝐬 𝐰𝐢𝐭𝐡 𝐭𝐞𝐚𝐦𝐬 𝐚𝐧𝐝 𝐜𝐥𝐢𝐞𝐧𝐭𝐬, tracking project progress, addressing issues, and delivering detailed status updates.• 𝐀𝐮𝐭𝐡𝐨𝐫𝐞𝐝 𝐚𝐧𝐝 𝐫𝐞𝐟𝐢𝐧𝐞𝐝 𝐒𝐎𝐏𝐬 and user documentation packages (Validation protocols,test scripts, FRS, URS, UAT, IQ/OQ/PQ, Trace Matrix, Summary Reports) ensuring compliance and testing with Agile methodologies and industry standards.•𝐀𝐮𝐝𝐢𝐭𝐞𝐝 𝐚𝐧𝐝 𝐚𝐝𝐝𝐫𝐞𝐬𝐬𝐞𝐝 𝐈𝐓 𝐬𝐲𝐬𝐭𝐞𝐦 𝐝𝐢𝐬𝐜𝐫𝐞𝐩𝐚𝐧𝐜𝐢𝐞𝐬 through GAP analysis and risk assessments, creating tailored solutions for identified issues. Show less

• 

  NeoGas Grid

  Feb 2025 - now

  IT Business Analyst

  Business Process Analysis;Responsible for SAP ISU suport:roles, autorizations, settings, forms;Compiling business requirements;Working within IT team for accomplish our goals.