Door categorieën bladeren
Ontdekken
Fiverr Pro
Nederlands
$
USD
PharmaAssurance
@shoel_sarkar
Pharma Expert, 15 Yrs in Deviation and QMS for Audit Ready CAPA Review
Bangladesh
Engels
Over mij
Welcome to PharmaAssurance — senior pharma quality consulting backed by 15+ years in sterile manufacturing.
Core Expertise:
• Deviation & CAPA Strategy: Review for audit-ready CAPAs.
• Aseptic Filling & CCS: Guidance on Contamination Control, Media Fills, and EU Annex 1.
• QMS & Audit Readiness: SOP optimization and inspection prep.
📌 Explore our active gigs for dedicated solutions in Deviations, CAPA, Audit Readiness, and Annex 1 CCS Gap Analysis!
Strict confidentiality guaranteed. Message us to solve your quality challenges today!
Skills
PharmaAssurance
offline •
Bekijk mijn diensten
Risicomanagement
I will provide expert gmp deviation investigation and audit ready capa strategy review
Risicomanagement
I will create your eu annex 1 contamination control strategy and aseptic documentation
Portfolio
Werkervaring
Lead Consultant & Founder | PharmaAssurance
Self Employed • ZZP
May 2021 - Present • 5 yrs 3 mos
Leading PharmaAssurance to provide specialized quality management and regulatory compliance solutions for pharmaceutical manufacturers and life science organizations worldwide. Proven Industry Leadership: Backed by 15+ years of hands-on leadership across major pharmaceutical manufacturers, including direct experience managing sterile production for leading global enterprises. Licensed Pharmacist with a Master's in Pharmacy. Core Consulting & Operations Expertise: • Aseptic Filling & Inspection: Comprehensive technical oversight of aseptic filling/sealing, over-capping, and visual inspection processes (manual and automated) of sterile products. • Sterile Processing & Operations: Deep technical expertise in sterile filtration & integrity testing, CIP/SIP systems, de-pyrogenation, terminal sterilization, and secondary packaging operations. • Deviation & CAPA Strategy: Expert evaluation, root cause analysis, and technical writing for audit-ready CAPAs and complex deviation investigations. • Regulatory & Audit Readiness: Aligning quality systems and operations with US FDA, EU Annex-1, WHO, and ICH guidelines to ensure successful inspection outcomes. • EU Annex 1 & CCS Implementation: Strategic oversight for Contamination Control Strategies (CCS), environmental monitoring, and media fill simulation reviews. • QMS & Qualification Review: Comprehensive auditing and optimization of SOPs, Change Controls, Annual Product Quality Reviews (PQR), equipment/utility qualification, and validation protocols. • Lean & Quality Systems: Integrating Lean Manufacturing and Six Sigma principles to optimize operational compliance without sacrificing efficiency. Explore Our Services: Review our portfolio of services covering Deviation review/CAPA design, EU Annex 1 CCS Gap Analysis, Aseptic Processing Oversight, and QMS Document Reviews. Need a tailored package? Message us now with your project details, and let’s create a custom solution for your compliance goals.
