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Anders Bronäs

Business Owner @Antx Ab

Stockholm County, SE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2025 — Present

Business Owner @Antx Ab

Danderyds kommun, SE

AntX Consulting offers expert GxP and ISO services for pharmaceutical, device, and life science sectors. Enhance compliance with tailored QMS solutions and strategic management services.Owner and founder: Glasskalas.seFounding partner: mmcs.se

EDUCATION

1995 — 1997

Stockholm University

Dutch

1995 — 1997

Stockholm University

Criminology A, Criminology B

1987 — 1991

International School Amsterdam

International Baccalaureate Diploma

2011 — 2011

Uppsala University

Pharmaceutics

2011 — 2011

Karolinska Institutet

Pharmacology

1992 — 1997

KTH Royal Institute of Technology

BSC, Chemical Engineering

SKILLS

PharmaceuticalsManufacturingV&VComplianceMedical DevicesSoftware DocumentationCalibrationTechnology TransferIso 9000PharmaceuticsQuality SystemsValidationCgmpQuality AssuranceAseptic ProcessingContinuous ImprovementLife SciencesQuality SystemSopAuditingGxpChange ManagementIsoProcess ImprovementFdaCleaning ValidationQuality ManagementRisk ManagementGdpDocumentation21 Cfr Part 11LifesciencesGmpComputer System ValidationBiopharmaceuticalsGlpQuality AuditingPharmaceutical IndustryCapaIso 13485

ABOUT ANDERS BRONÄS

20+ years experience managing quality assurance within the pharmaceutical and Life science industry. Managing QA for Medical devices and pharmaceuticals in the Nordic region, under my leadership adherence to stringent GMP, GDP, ISO 9001 and ISO 13485 standards is secured. As the Responsible Person (RP) for GDP/WDA operations, the focus is on elevating quality systems, managing deviations, CAPAs, and field corrective actions. With a strong grounding in GMP/GDP compliance and quality systems design, i have lead teams to successfully maintain the company\'s rigorous commitment to international regulatory standards. Leading a team across multiple European countries, we\'ve fostered effective communication and streamlined quality assurance processes. Expertise in: QA Leadership, QMS FDA and EU GMP / cGMP compliance, Inspections & Audits, GMP/GDP Training, Validation, Metrology, Calibration, VMP, SOPs, Quality Systems, Risk Analysis, PQR ISO 9001/14001/13485 WHO/EU GDP, cGMP, and local regulatory requirements.

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