Remote Senior Pharmaceutical QA Specialist

Placements24

Lorenziberg

Remote

EUR 90,000 - 140,000

Full time

2 days ago
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Benefits offered by this job

Competitive salary
Health, dental, vision insurance
Retirement savings plan
Paid time off
Remote work from home

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team dedicated to ensuring product and process compliance with cGMP and regulatory standards. You will develop, implement, and maintain a robust Quality Management System (QMS) and lead audits across global operations.

The role requires 7+ years in QA/QC, strong regulatory knowledge, auditing, CAPA and change control expertise, and excellent remote collaboration and documentation abilities.

Qualifications

  • Bachelor’s degree in Pharmacy, Chemistry, Microbiology or related life sciences.
  • Minimum 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
  • Strong knowledge of cGMP, ICH guidelines and regulatory standards (FDA, EMA, SAHPRA).
  • Proven experience in auditing, deviation management, CAPA and change control processes.
  • Excellent written and verbal communication for remote collaboration and documentation.

Responsibilities

  • Develop, implement, and maintain the Quality Management System (QMS) in line with cGMP and regulations.
  • Conduct internal and external audits of suppliers, contract manufacturers, and processes.
  • Manage deviations, OOS results, and CAPA processes.
  • Review and approve batch records, validation protocols, and quality docs.
  • Participate in regulatory inspections and respond to agency queries.
  • Provide training on QA principles and GMP compliance.

Skills

Quality Assurance
Auditing
CAPA
Change Control
Regulatory Compliance
Analytical Thinking
Remote Collaboration

Education

Bachelor's degree in Pharmacy, Chemistry, or Microbiology

Tools

Quality Management Software

Job description

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team dedicated to ensuring product and process compliance with cGMP and regulatory standards. You will develop, implement, and maintain a robust Quality Management System (QMS) and lead audits across global operations.

The role requires 7+ years in QA/QC, strong regulatory knowledge, auditing, CAPA and change control expertise, and excellent remote collaboration and documentation abilities.

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