{
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  "basics": {
    "name": "Mobarshir Junaid Shaikh",
    "label": "Analytical QA/QC Specialist",
    "summary": "Analytical QA/QC Specialist with over 10 years of experience in GMP-regulated pharmaceutical environments across the entire value chain. Proven expertise in OOS/OOT investigations, audit trail review, stability studies, and sample management. Experienced in EU-GMP, USFDA, and MHRA compliance, leading international inspections, and data integrity according to ALCOA+.",
    "location": "Frankfurt am Main, Deutschland",
    "profiles": [
      {
        "network": "LinkedIn",
        "username": "mj-shaikh-60971a13b",
        "url": "https://linkedin.com/in/mj-shaikh-60971a13b"
      }
    ]
  },
  "work": [
    {
      "company": "Sovereign Pharma Pvt. Ltd., Indien",
      "position": "Executive Analytical QA",
      "startDate": "2023-09",
      "endDate": "2025-09",
      "highlights": [
        "Served as single point of contact for EU, MHRA, USFDA, and other regulatory inspections representing quality department",
        "Planned, coordinated, and led regulatory inspections with 100% complete and inspection-ready documentation",
        "Initiated and established four-year OOS/OOT trend analysis programs to reduce risks early; trained 25+ staff in data integrity and deviation management",
        "Conducted and documented method executions, chromatographic controls (Empower, Chromeleon) and audit trails per ALCOA+",
        "Managed creation, review, and approval of SOPs, deviation reports, CAPAs, and change controls in TrackWise system",
        "Performed internal QC audits with 95% deviation closure rate within 30 days",
        "Planned and accompanied 20+ supplier and contract lab audits including detailed reports and corrective action follow-up",
        "Achieved 15% sustainable efficiency improvement through targeted SOP optimization and process streamlining"
      ]
    },
    {
      "company": "Exemed Pharmaceuticals, Indien",
      "position": "Executive Analytical QA",
      "startDate": "2021-08",
      "endDate": "2023-09",
      "highlights": [
        "Led Analytical QA team of 65+ QC analysts ensuring compliance with EU-GMP and international quality standards",
        "Reviewed and approved batch protocols, Certificates of Analysis (CoAs), deviations, CAPAs, and change controls in electronic QMS",
        "Reduced batch release time by 15% through process optimization and closer QC-QA coordination",
        "Planned, documented, and supported equipment qualifications and GMP supplier evaluation and monitoring"
      ]
    },
    {
      "company": "Umedica Laboratories Ltd., Indien",
      "position": "Senior Officer – Quality Control",
      "startDate": "2020-08",
      "endDate": "2021-08",
      "highlights": [
        "Performed systematic audit trail reviews for HPLC, GC, UPLC, UV, and stability chamber systems to ensure data integrity and traceability",
        "Managed data review for raw materials, packaging, finished products, and ongoing stability studies per GMP and ALCOA+ requirements"
      ]
    },
    {
      "company": "Mylan Laboratories Limited, Indien",
      "position": "Senior Chemist",
      "startDate": "2017-09",
      "endDate": "2020-08",
      "highlights": [
        "Conducted routine and out-of-specification analyses for raw materials, intermediates, and finished products per validated test methods",
        "Supported preparation and execution of regulatory and customer audits; prepared and reviewed analytical reports and test protocols",
        "Contributed to batch release documentation and maintenance of reference and reserve samples"
      ]
    },
    {
      "company": "IPCA Laboratories Limited, Indien",
      "position": "Junior Officer – Quality Control",
      "startDate": "2015-04",
      "endDate": "2017-09",
      "highlights": [
        "Tested raw materials, packaging materials, stability, and finished product samples per GLP and pharmacopoeia standards",
        "Managed reference standards and reserve samples (Control/Reserve Sample Management) and performed follow-up analyses"
      ]
    }
  ],
  "education": [
    {
      "institution": "Savitribai Phule Pune University, Indien",
      "degree": "Bachelor of Pharmacy",
      "endDate": "2014"
    }
  ],
  "skills": [
    "Regulatory Compliance: EU-GMP, USFDA, MHRA, WHO cGMP, ICH Q7, ICH Q10, ALCOA+, Inspektionsbereitschaft, Datenintegrität",
    "Analytical QA/QC: OOS, OOT, Methodenvalidierung, Methodenverifizierung, Methodentransfer, Stabilitätsstudien, Audit-Trail-Review, Chargenfreigabe, CAPA, Änderungsontrolle, Abweichungsmanagement, Chargenprotokollprüfung, SOP-Lifecycle, Referenz- und Rückstellmustermanagement (Control/Reserve Sample Management)",
    "Instrumente: HPLC, UPLC, LC/MS, UV/Vis, Dissolution, FTIR, TOC, Karl-Fischer, GC, pH-Meter",
    "Software & Systeme: TrackWise, LIMS, QMS, DMS, Empower, Chromeleon, LabSolutions, SAP, Minitab, JMP, 21 CFR Part 11"
  ],
  "languages": [
    {
      "language": "English",
      "fluency": "Fluent"
    },
    {
      "language": "Hindi",
      "fluency": "Native"
    },
    {
      "language": "German",
      "fluency": "Intermediate"
    }
  ],
  "certificates": [
    {
      "name": "ISO 9001:2015 – QMS Auditor"
    },
    {
      "name": "Certified Quality Auditor (CQA)"
    },
    {
      "name": "21 CFR Part 11 Compliance"
    }
  ],
  "availability": {
    "status": "open"
  },
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      "Executive Analytical QA",
      "Sovereign Pharma Pvt. Ltd., Indien",
      "Exemed Pharmaceuticals, Indien",
      "Senior Officer – Quality Control",
      "Umedica Laboratories Ltd., Indien",
      "Senior Chemist",
      "Mylan Laboratories Limited, Indien",
      "Junior Officer – Quality Control",
      "IPCA Laboratories Limited, Indien",
      "English",
      "Hindi",
      "German",
      "ISO 9001:2015 – QMS Auditor",
      "Certified Quality Auditor (CQA)",
      "21 CFR Part 11 Compliance",
      "Analytical QA/QC Specialist"
    ],
    "yearsOfExperience": 0,
    "seniority": "entry",
    "highestEducation": "Bachelor's"
  },
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    "platform": "freecv.org"
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    "primary": "en"
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    "lastModified": "2026-09-21T21:56:35.378Z",
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