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Home›Careers›QA Specialist, Validation & Qualification

QA Specialist, Validation & Qualification

Quality Assurance · Alexandria · Full-time · Mid-level

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Quality AssuranceQA Specialist, Validation & Qualification
←Other roles
LocationAlexandria
TypeFull-time
LevelMid-level

Role Overview

Own the validation lifecycle across Pharco's manufacturing sites, from equipment qualification to cleaning and process validation. You will be a subject-matter expert relied upon by cross-functional teams to ensure products are consistently manufactured to the highest quality standards.

Key Responsibilities

  • Author and execute Validation Master Plans, URS, IQ/OQ/PQ protocols and reports
  • Lead cleaning validation and annual product review activities
  • Support computer system validation (CSV) under GAMP 5 guidelines
  • Represent QA in project teams during facility and equipment changes
  • Maintain the site validation programme in a state of continuous inspection readiness

Requirements

  • B.Sc. in Pharmacy, Chemistry, or Engineering
  • 3+ years in QA validation within a pharmaceutical manufacturing setting
  • In-depth knowledge of ICH Q2, Q7, and relevant GMP regulations
  • Strong technical writing skills for protocol and report authoring
  • Attention to detail and ability to manage multiple concurrent projects

Nice to Have

  • Experience with computerised systems validation (SAP, LIMS, MES)
  • Working knowledge of annex 15 EU GMP guidelines
  • Exposure to FDA warning letter remediation
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Questions? Email careers@pharco-corp.com