Hire the Best Pharmaceutical Industry Specialists
in Germany

Welcome! I am Yamira Munkel, a seasoned Regulatory and Quality Expert with over a decade of experience in the pharmaceutical industry. With GxP-Background. Certified PRRC (EU MDR 2017/745 / EU IVDR 2017/746, Responsible Person (GDP Directive 2001/83/EC), Responsible Person (Cosmetics EU Cosmetics Regulation 1223/2009). I am passionate about guiding businesses through complex pharmaceutical regulatory requirements. My expertise includes technical writing, such as Standard Operating Procedures (SOPs), and in-depth knowledge of Quality Management Systems (QMS) that comply with ISO standards and global regulatory frameworks. Furthermore, my experience encompasses EudraLex Volume 4, ensuring that pharmaceutical products adhere to jurisdictional compliance standards. I also possess extensive expertise in GDPR, Computer System Validation (CSV), lead auditing, CE certification, and ISO 9001 and ISO 13485 compliance. Research, technical documentation, and regulatory submissions are among my core competencies. If you require regulatory affairs expertise, quality management system guidance, or support with regulatory submissions in the pharmaceutical industry, I am here to assist. My vast experience in regulatory and quality affairs ensures that your products meet international standards and compliance requirements. Let’s collaborate to bring your pharmaceutical products to market with confidence and compliance! I look forward to connecting with you!

Quality and IT professional with 25+ years of experience in pharmaceutical, IT, and global process improvement roles. Proven expertise in leading data & digital projects, AI initiatives, and computerized system compliance in regulated pharma environments. Skilled in GxP compliance, digital transformation, stakeholder engagement, and global team leadership. Recognized for driving organizational upskilling, innovation, and operational excellence. Core Competencies: • GxP & Regulatory Compliance (FDA, EU, AGES) for computerized systems • Digitalization Initiatives in pharma • Project & Program Management – PMP, Agile, SAFe • Leading Global Cross-Functional Teams & Networks • Business Process Improvement & Lean Six Sigma Black Belt • IT Systems Architecture, ALM & LIMS / QMS • Change Control & GMP-compliant system implementation • Stakeholder Management & Senior Leadership Communication • Technical Documentation: SRS, SDS, SOPs, User Stories, Test Scenarios Technology Skills • ALM & SDLC Management: JIRA, Polarion, Confluence, Azure • Process Modelling : Camunda, Miro, Visio, Lucid, Smart Draw • Database Design & Modeling: MS Access, Oracle Designer • Statistical Analysis: MS Excel, Minitab • CRM Systems: Salesforce, Zoho, HubSpot, Vtiger • User Journey Design: Balsamiq, Visio, HotGloo, Smart Draw, Mockup, Miro • Microsoft: MS Office (Excel, Word, PowerPoint), Azure • Programming Language: Python, JavaScript, C/C++, HTML, Velocity & PL/SQL Awards & Recognitions: • Top 10 Best IT Systems Analyst Worldwide (ODesk/Upwork.com 2014 & 2015) • #1 Top Talent in Six Sigma Process Improvement, ITIL Expert & Business Process Architecture (Upwork.com 2016) • Novartis Digital Innovation Champion (Novartis GmbH- 2019) • Novartis Certified Investigator (Novartis GmbH- 2018) • Novartis AI Discoverer (Novartis GmbH- 2022)

I'm a PhD chemist and senior IT consultant with over 11 years of experience specializing in LIMS implementations and lab digitalization for the pharmaceutical industry. I support clients from requirements to validated solutions – with a focus on SampleManager™, LabVantage, other LIMS products, and reporting tools like JasperReports and Crystal Reports. I bring basic, process/integration-level experience with SAP ERP (QM/MM) ↔ LIMS (inspection-lot trigger, usage-decision feedback, master-data harmonization). Trusted by clients like AbbVie, global CMOs, and biotech labs to design and deliver validated LIMS/reporting solutions across Europe and the US. Key strengths: • Strong C#/.NET + SQL (Oracle & T-SQL) background • GxP-compliant report design (JasperReports, Crystal) • Computer System Validation (CSV): GAMP 5, EU GMP Annex 11, US FDA 21 CFR Part 11 • Hands-on experience with LIMS: SampleManager™, LabVantage, and others • Deep knowledge of LES, ELN, and MES • IT Security • Smooth coordination between QA, IT & validation teams Project Highlight: Delivered a validated stability reporting solution based on Oracle SQL and JasperReports, fully integrated with SampleManager™ via C#. Covered full lifecycle: concept, spec writing, implementation, validation support, and cross-team knowledge transfer – from kickoff to go-live in under 12 months. Let’s bring your lab systems to the next level! Note: My employment history shown here is a selected excerpt.

I’m a licensed pharmacist with a strong background in pharmaceutical research and medical writing. I specialize in reviewing drug information, summarizing clinical studies, explaining side effects, and creating scientific content that is accurate and accessible. I also design clear and professional medical figures for publications and presentations. Let’s work together to bring clarity to complex medical topics!

Experienced, passionate and business-oriented molecular microbiologist (Ph. D) with a 6+ year professional background in quality management systems under ISO 17025 and ISO 13485. Diverse knowledge of microbial biology, bioprocessing, analytical chemistry, QHSE, product safety regulatory compliance, laboratory design and buildout as well as test method development and validation.