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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 122375

QA Expert

  • Pharma & Biotech
  • Asap
  • Release of GMP-Batches, Batch Record Review, PQR
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Pharmaceutics, PhD & Biology, Diploma
Language Skills
German (native), English (business fluent)
Relevant Expertise
Expertise: Senior QA Manager, QA/ QC/ Production, Release of GMP-Batches, Batch Record Review, PQR , Deviations, CAPAs, Change Control, Complaint Management, Supplier, Audits, Trackwise, CMO, GMP/ GDP, Logistics & Packaging, Regulatory Affairs, Pharma/ Biotech

Key-Facts

  • Profound experience as Senior QA Manager (Deviations, CAPAs, Batch Record Reviews, PQR, Implementation of QMS Systems)

  • Combines expertise from Quality and Production (incl. Packaging & Logistics) for optimal Product Management

  • Successfully placed by K-Recruiting multiple times and received only excellent feedback (also multiple extensions)

Extract from Previous Activities

2022 – 2023

Pharmaceutical Company, Germany (via K-Recruiting)

PQR Expert

  • Execution of Product Quality Reviews

  • Consultancy regarding GMP-compliant documentation

2022

Biotechnological Company, Germany (via K-Recruiting)

PQR Expert

  • Execution of Product Quality Reviews

  • Compilation of Product Quality Review Summaries

  • Documentation

  • Consultancy for the process optimization of QA-Processes

2021

Pharmaceutical Company, Germany

Senior QA Consultant – Quality Assurance Disposition

  • Technical release of GMP-batches

  • Change Control tracking / Trackwise

  • Deviation investigation and tracking / Trackwise

2021

Pharmaceutical Company, Germany

Senior QA Consultant – Quality Assurance Supplier Qualification

  • Support of Quality Assurance Agreements

  • GMP-Supplier Audits

  • Tracking of action due to observation

2020 – 2021

Pharmaceutical Company, Germany

Senior QA Consultant – Quality Assurance / Change Control

  • Support of internal / external changes

  • Tracking of variations

2020 – 2021

Pharmaceutical Company, Germany

Senior QA Consultant – Quality Assurance

  • Support of internal / external Changes

  • Preparation of BSE risk assessment

  • Process Update supplier qualification

  • Data Analysis for implementation of Reduced testing procedure

2019 – 2020

Biotechnological Company, Germany

Senior QA Consultant – Compliant Management

  • Tracking of complaints: Record and documentation of investigation (TrackWise)

2019 – 2020

Medical Devices & Medicinal Products Company, Germany

Senior QA Consultant – Implementation GDP quality system

  • Planning, preparation and implementation of a quality system according to § 52 a AMG (GDP)

  • Planning and implementation of storage logistic, environmental monitoring system

  • Implementation of Quality Agreements transport companies