Freelance QA Manager

2 weken geleden

Utrecht, Utrecht, Nederland EPM Scientific Voltijd € 60.000 - € 100.000 per jaar

Role Overview

A freelance QA Manager is required to provide interim support at a GMP‑licensed site specializing in sterile and biologics manufacturing. The consultant will ensure compliance with EU GMP and Annex 1, strengthen quality systems, and prepare the site for upcoming regulatory inspections.

Key Responsibilities

  • Oversee and maintain site quality systems, including deviations, CAPAs, change control, and documentation.
  • Support aseptic operations and sterile manufacturing with QA oversight and risk‑based decision‑making.
  • Review and approve validation protocols, qualification reports, and change control documentation.
  • Lead inspection readiness activities, including internal audits, mock inspections, and corrective action follow‑up.
  • Provide QA input into production, QC, engineering, and regulatory projects to ensure compliance alignment.
  • Train and coach staff to reinforce GMP culture and continuous improvement.
  • Support batch record review and liaise with QPs to facilitate timely product release.

Candidate Profile

  • Minimum 8 years' experience in pharmaceutical QA, with strong exposure to sterile/aseptic manufacturing.
  • In‑depth knowledge of EU GMP, Annex 1, and regulatory expectations for biologics/sterile injectables.
  • Proven track record in inspection readiness and remediation projects.
  • Strong communicator with ability to influence cross‑functional teams.
  • Must be based in the Netherlands; ability to work on‑site in the central region (Utrecht and surrounding provinces).
  • Dutch language skills strongly preferred; fluent English required.
  • Previous interim/freelance QA leadership experience advantageous.

Assignment Details

  • Start Date: Negotiable
  • Duration: 6-12 months (potential extension)
  • Location: On‑site in the central Netherlands (Utrecht region and surroundings), with limited flexibility for remote work

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