Soledad Hueros
Quality and Technical Management, Compliance, Pharmacovigilance, Innovation and Improvement.
- Role
- Qa Senior Manager Site Reponsible at Almirall
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Soledad Hueros
Lean Manufacturing ~ Quality Assurance (QA)~ Regulatory Affairs Technology Transfer ~ Process & Cleaning Validation ~ Equipment Qualification & EngineeringBilingual professional with 20 years of experience in pharmaceutical industry and exceptional technical and quality orientation capabilities. Highly knowledgeable of ICH, US FDA cGMP and international cGMP regulations. Skillfully identify and resolve complex technical problems to uphold strict timelines. Proven ability to work well under pressure and effectively prioritize tasks in deadline-driven environments. Select achievements include:• Awarded for successful pre-approval inspection (PAI) of first quality by design (QbD) product developed by AstraZeneca PR. • Recognized for generating favorable results for Improvement Investigation Program as Quality Improver; reduced overdue investigations from 68 to 0 and significantly minimized repeated events. • Established effective knowledge transfer model between Operations and R&D personnel.
Experience
Qa Senior Manager Site Reponsible
Mar 2026 — Present
Education
Universidad de Alcalá
Licentiate Biological Sciences
Universidad de Puerto Rico
Courses for PhD, Molecular Biology & Genetics
1993
Universidad de Alcalá
Bachelor's degree, Molecular Biology
Skills
- • Quality Risk Management: Ich Q8/Q9/Q10, Gamp V and Astm E2500
- • Problem Solving and Decision Making
- Training for Managers and Supervisors
- • Fda System-Based Inspections of Drug Companies
- • Project Management
- • Aseptic Processing
- • Freeze Drying Course
- • Current Good Manufacturing Practices (Cgmps) and Advance Cgmps for Parenterals
- • Effective Investigation Reports
- Capas
- Oral Solid Dosage Forms
- Microsoft Project Management
- Microsoft Office
- Trackwise
- Minitab
- Statistics
- Visio
- Ldms
- Sap
- Adobe Acrobat
- V&V
- Gmp
- Fda
- Capa
- Quality Assurance
- Sop
- Aseptic Processing
- Ms Project
- Technology Transfer
- Change Control
- Validation
- 21 Cfr Part 11
- Quality Improvement
- People Skills
- Pharmaceutical Industry
- Business Process Improvement
- Quality Control
- Regulatory Affairs
- Cross Cultural Management
- Quality System
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