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Sandeep suresh

Bis 2026, Quality Assurance Specialist, Alvogen Group, Nantou, Taiwan
Berlin, Deutschland

Fähigkeiten und Kenntnisse

Chromatography & Analytical Techniques
Quality Management Systems (QMS)
Computer System Validation
Analytical Method Validation (LIRs and CAPA Coordination)
Technology Transfer & Risk Management
Deviation & Investigation Management
People Management
Project/Resource Management
Quality Metrics
Cross-Functional Co-ordination
Conflict Management
Audit Readiness Support
Oral Solid Dosage Forms
Soft-Gel Formulations
Medical devices
APIs Vendor
Management
Quality Systems
Risk Management
audits
manufacturing quality
development quality
compliance
product lifecycle
complex
GMP Compliance
ISO 13485:2016
MDSAP
MDR
ICH
Guidelines
EU GMP Annex 1
quality governance
providing quality
CMOs
CDMOs
manufacturing
partners
analytical method validation
Quality Risk Management
ICH Q9
analytical test
specifications
validation documentation
completed 36+
Quality Assurance
Pharmaceutical Quality Assurance
Quality Management Systems
Development Quality
Corporate Quality
USFDA
EMA
WHO
PIC/S
Regulatory Compliance
Inspection Readiness
TrackWise
QUMAS
PAS-X
SAP
Caliber QMS
SharePoint
Empower 3
Chromeleon
MS Visio
Microsoft Excel
Microsoft Word
Microsoft Powerpoint
SCADA
HMI
HPLC
GC
XRD
TGA
Dissolution Systems
German
Cross-functional Leadership
Continuous Improvement
Stability Program Management
ANDA & EU Dossier Support
CMC Documentation
Documentation Management
Equipment Qualification
URS
DQ
IQ
OQ
PQ
Analytical Method Validation
Cleaning Validation
Process Validation
Validation Management
OOS/OOT Investigations
Change Control
Root Cause Analysis
Deviation Investigation
CAPA Management
Internal & External Audits
Vendor Qualification & Management
CMO
CDMO
Quality Oversight
Technology transfer
Data Integrity
ALCOA++
pharmaceutical quality
audit focused
Manufacturing
regulatory compliance
supporting
ROW markets
Passionate
ALCOA
principle
Strengthening
Inspection
preparedness
Site Quality Assurance
APIs Vendor Management
People skills
SOP preparation
structured gap analysis
150+ SOPs
streamline processes
promote leaner compliance
QMS modules
CAPA
Deviation
OOS
OOT
verify compliance
Microsoft Office
MS Word
Excel
PowerPoint
Visio
Track Wise
Empower-3
Calibre QMS
MBR/MPR via PASx

Werdegang

Berufserfahrung von Sandeep suresh

  • 5 Jahre und 2 Monate, Jan. 2021 - Feb. 2026

    Quality Assurance Specialist

    Alvogen Group, Nantou, Taiwan

  • 2 Jahre und 9 Monate, Apr. 2018 - Dez. 2020

    Team Manager Quality Assurance

    Laurus Labs Limited, Hyderabad, India

  • 1 Jahr und 8 Monate, Sep. 2016 - Apr. 2018

    Manager Quality Assurance, Technology transfer/Audit and compliance

    Granules India Ltd, Hyderabad India

Sprachen

  • Deutsch

    A1-A2 (Grundkenntnisse)

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