Quality Assurance Specialist (Pharmaceutical)

Placements24

Mbombela (Nelspruit)

Hybrid

ZAR 450,000 - 750,000

Full time

13 days ago
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Benefits offered by this job

Remote work setup
Health, dental, and vision insurance
Paid time off
Career growth opportunities

Job summary

Placements24 is seeking a dedicated Quality Assurance Specialist for a fully remote role supporting pharmaceutical operations across sites relevant to Nelspruit.

You will review critical quality documents, lead audits, manage deviations and CAPAs, and drive continuous improvement to ensure regulatory alignment with cGMP and SAHPRA standards.

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, Biology or a related scientific field.
  • Minimum of 3 years of experience in Quality Assurance within the pharmaceutical sector.
  • Strong understanding of cGMP and SAHPRA regulatory requirements.
  • Experience with document control, change control and deviation management.

Responsibilities

  • Review and approve quality documents including batch records and SOPs.
  • Lead internal audits and support regulatory inspections and customer audits.
  • Investigate deviations, non-conformances and CAPAs to closure.
  • Support change control and assess quality impact of changes.
  • Monitor quality metrics and drive continuous improvement.
  • Provide QA training and support to manufacturing and labs.

Skills

Attention to detail
Audit readiness
Regulatory compliance
Quality improvement
Documentation review

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or related field

Tools

Quality management software

Job description

About the Role

Our client is seeking a dedicated Quality Assurance Specialist to bolster their quality management systems, operating in a fully remote capacity to support operations across various sites, including those relevant to Nelspruit . This role is crucial for ensuring that all pharmaceutical manufacturing and development activities adhere to stringent regulatory standards and internal quality policies. You will be involved in audits, documentation review, deviation management, and continuous improvement initiatives, ensuring the highest quality of products reaching patients. This position offers the flexibility of remote work while contributing significantly to pharmaceutical quality excellence.

Key Responsibilities
  • Review and approve critical quality documents, including batch records, SOPs, validation protocols, and reports.
  • Conduct internal audits and support external regulatory inspections and customer audits.
  • Manage and investigate deviations, non-conformances, and CAPAs to ensure timely and effective resolution.
  • Participate in change control processes, assessing the quality impact of proposed changes.
  • Monitor and analyze quality metrics to identify trends and opportunities for improvement.
  • Provide QA training and support to manufacturing, laboratory, and other relevant departments.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
  • Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or related industry.
  • Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory requirements (e.g., SAHPRA).
  • Experience with quality management systems, including document control, change control, and deviation management.
  • Excellent attention to detail, organizational skills, and ability to manage multiple tasks.
  • Proficiency in using quality management software and standard office applications.
Benefits
  • Competitive annual salary and performance-based bonus.
  • Comprehensive remote work setup support.
  • Health, dental, and vision insurance benefits.
  • Generous paid time off and holidays.
  • Significant opportunities for career growth in quality assurance within a reputable pharmaceutical company.
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