Senior Pharma QA Analyst – Drive Quality & Compliance Impact

Placements24

Queenstown

Sur place

NZD 76 000 - 119 000

Plein temps

Il y a 3 jours
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Avantages offerts par ce poste

Health insurance
Retirement savings plan
Paid time off
Professional development opportunities
Team collaboration in QA excellence

Résumé du poste

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Analyst to join our client’s team in Queenstown. The role focuses on ensuring products meet GMP, regulatory and quality standards, and involves maintaining and improving the QMS, handling CAPA, deviation management, and audits.

You will collaborate with production, R&D, and regulatory affairs, lead internal audits, review batch records, and provide training on QA principles to strengthen compliance and product integrity across the

Qualifications

  • Minimum 5 years of experience in pharmaceutical quality assurance.
  • Degree in Pharmacy, Chemistry, Biology, or related field; Master's preferred.
  • GMP and ICH regulatory knowledge.
  • Experience with QMS, change control, deviation management, and CAPA.
  • Strong analytical, documentation, and communication skills.

Responsabilités

  • Develop, implement, and maintain QA policies and procedures in line with GMP and regulatory standards.
  • Conduct regular internal audits of manufacturing processes, documentation, and facilities.
  • Review and approve batch records, validation protocols, and deviation reports.
  • Investigate product quality complaints and CAPA to identify root causes.
  • Monitor quality metrics and report findings to management.
  • Collaborate with production, R&D, and regulatory affairs to resolve QA issues.
  • Participate in external regulatory inspections and audits.
  • Provide training on QA principles to personnel.
  • Stay updated on industry trends and regulatory changes.

Connaissances

GMP knowledge
ICH guidelines
CAPA and deviation handling
Audit skills
QMS experience
Documentation and report writing
Analytical thinking
Regulatory communication

Formation

Bachelor's degree in Pharmacy, Chemistry, or Biology
Master's degree is a plus

Outils

QMS software
Microsoft Office

Description du poste

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Analyst to join our client’s team in Queenstown. The role focuses on ensuring products meet GMP, regulatory and quality standards, and involves maintaining and improving the QMS, handling CAPA, deviation management, and audits.

You will collaborate with production, R&D, and regulatory affairs, lead internal audits, review batch records, and provide training on QA principles to strengthen compliance and product integrity across the

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