Remote Senior QA Specialist - GMP & Compliance Leader

Placements24; Queenstown; Remote; NZD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Health, dental, and vision insurance

Retirement savings plan

Generous paid time off

Zusammenfassung

Placements24 is recruiting on behalf of a leading pharmaceutical organization for a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team. You will ensure products and processes meet cGMP, ICH, and FDA/EMA standards, and lead QA activities across the product lifecycle.

The role requires seven+ years in QA/QC, a life sciences degree, strong auditing, CAPA, and change-control experience, with the ability to collaborate with global teams via digital platforms.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science.
• 7+ years of experience in pharmaceutical QA or QC.
• Strong knowledge of cGMP, ICH guidelines and regulatory standards (FDA/EMA).
• Auditing, deviation management, CAPA and change control experience.
• Remote collaboration and excellent documentation skills.

Aufgaben

• Develop, maintain, and improve the QMS in line with cGMP and regulations.
• Conduct internal and external audits of suppliers, CMO, and processes.
• Manage deviations, OOS, CAPA, and change control workflows.
• Review batch records, validation docs, and quality records.
• Support regulatory inspections and respond to agency queries.
• Provide training on QA principles and GMP compliance.
• Monitor quality metrics and report trends for improvement.
• Collaborate with R&D, Manufacturing, QC to integrate quality across the lifecycle.
• Stay updated with evolving regulatory requirements and best practices.

Kenntnisse

GMP knowledge

Auditing

CAPA

Change control

Quality metrics

Remote collaboration

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Microbiology or related life science

Tools

Quality management software

Document control systems

Jobbeschreibung

Placements24 is recruiting on behalf of a leading pharmaceutical organization for a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team. You will ensure products and processes meet cGMP, ICH, and FDA/EMA standards, and lead QA activities across the product lifecycle.

The role requires seven+ years in QA/QC, a life sciences degree, strong auditing, CAPA, and change-control experience, with the ability to collaborate with global teams via digital platforms.