Quality Assurance Specialist - Pharmaceutical Compliance

Placements24

Vereeniging

Hybrid

ZAR 480,000 - 720,000

Full time

4 days ago
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Benefits offered by this job

Health benefits
Retirement benefits
Hybrid work arrangement

Job summary

Placements24 seeks a diligent Quality Assurance Specialist to uphold GMP standards in Vereeniging, Gauteng. You will develop and maintain QMS, conduct audits, review quality documentation, investigate deviations, and support CAPA processes to ensure patient safety and product efficacy.

The role requires a Bachelor’s degree in a related field and 3+ years in QA/QC within pharma, with strong attention to detail, communication skills, and proficiency in quality management software.

Qualifications

  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
  • Minimum of 3 years in a Quality Assurance or Quality Control role within the pharmaceutical industry.
  • Strong understanding of GMP, ICH guidelines, and other regulatory standards.
  • Experience with auditing, deviation management, and CAPA processes.
  • Excellent attention to detail and organizational skills.
  • Strong written and verbal communication abilities.

Responsibilities

  • Assist in the development, implementation, and maintenance of the Quality Management System (QMS).
  • Conduct internal audits and participate in external audits of suppliers and manufacturing sites.
  • Review and approve quality-related documentation, including SOPs, batch records, and validation protocols.
  • Investigate deviations, CAPAs, and OOS results.
  • Ensure compliance with GMP, regulatory guidelines, and company policies.
  • Participate in quality risk management activities.
  • Support change control processes and ensure all changes are properly assessed and implemented.
  • Monitor key quality metrics and prepare quality reports.
  • Provide training to personnel on quality systems and GMP requirements.

Skills

Attention to detail
Organizational skills
Written and verbal communication
Problem-solving

Education

Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field

Tools

Quality management software
Microsoft Office Suite

Job description

About the Role Our client, a respected pharmaceutical company, is seeking a diligent Quality Assurance Specialist to join their team in Vereeniging, Gauteng . This role is pivotal in upholding the highest standards of quality and compliance across all pharmaceutical operations. You will be involved in developing, implementing, and maintaining quality systems, conducting audits, and ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. This is an excellent opportunity for a detail-oriented individual to make a significant contribution to patient safety and product efficacy. We are dedicated to fostering a culture of quality excellence and are looking for a proactive individual to champion these efforts. The successful candidate will be instrumental in maintaining our compliance posture.

Key Responsibilities
  • Assist in the development, implementation, and maintenance of the Quality Management System (QMS).
  • Conduct internal audits and participate in external audits of suppliers and manufacturing sites.
  • Review and approve quality-related documentation, including SOPs, batch records, and validation protocols.
  • Investigate deviations, CAPAs (Corrective and Preventive Actions), and out-of-specification (OOS) results.
  • Ensure compliance with GMP, regulatory guidelines, and company policies.
  • Participate in quality risk management activities.
  • Support change control processes and ensure all changes are properly assessed and implemented.
  • Monitor key quality metrics and prepare quality reports.
  • Provide training to personnel on quality systems and GMP requirements.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
  • Minimum of 3 years of experience in a Quality Assurance or Quality Control role within the pharmaceutical industry.
  • Strong understanding of GMP, ICH guidelines, and other relevant regulatory standards.
  • Experience with auditing, deviation management, and CAPA processes.
  • Excellent attention to detail and organizational skills.
  • Strong written and verbal communication abilities.
  • Proficiency in Microsoft Office Suite and quality management software is a plus.
  • Ability to work effectively both independently and as part of a team.
  • Proactive approach to problem-solving and continuous improvement.
Benefits
  • Our client offers a competitive salary, a comprehensive benefits package including health and retirement benefits, and opportunities for professional growth and development. This hybrid role allows for a flexible work arrangement in Vereeniging . Join a company that values its employees and invests in their training and well-being, fostering a positive and productive work environment.
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