Pharma QA Specialist: GMP, Batch Records & CAPAs

Placements24; Stellenbosch; Hybrid; ZAR 360.000 - 600.000; Vollzeit

Benefits dieser Stelle

Medical benefits

Retirement benefits

Professional development opportunities

Zusammenfassung

Placements24 has partnered with a reputable pharmaceutical company in Paarl, Western Cape, to recruit a diligent Quality Assurance Specialist. The role focuses on ensuring products meet quality, safety, and regulatory standards through batch record reviews, deviation management, change control, and internal audits.

The successful candidate will possess a Bachelor's degree in a life science, at least 3 years' QA/QC experience in pharma, and a strong GMP understanding.

Qualifikationen

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or related life science.
• Minimum of 3 years in Quality Assurance/Quality Control in the pharmaceutical industry.
• Solid understanding of Good Manufacturing Practices (GMP) and other regulatory guidelines.
• Experience with batch record review, deviation management, and change control procedures.
• Strong analytical and problem-solving skills with keen attention to detail.
• Excellent written and verbal communication skills in English.
• Ability to work independently and collaboratively within a team.
• Proficiency in Microsoft Office Suite and familiarity with quality management software is desirable.

Aufgaben

• Review and approve batch manufacturing records (BMRs) and associated documentation to ensure compliance with established procedures and specifications.
• Manage deviations, investigations, and CAPAs (Corrective and Preventive Actions) to address quality issues effectively.
• Oversee the change control process, assessing the impact of proposed changes on product quality and regulatory compliance.
• Conduct internal audits of manufacturing processes, quality systems, and documentation to identify areas for improvement.
• Participate in external audits by regulatory agencies and customers.
• Develop and maintain Standard Operating Procedures (SOPs) and other quality system documents.
• Provide QA support and training to manufacturing and other operational departments.
• Monitor key quality metrics and contribute to continuous improvement initiatives.
• Ensure compliance with GMP, GDP, and relevant pharmaceutical regulations.
• Manage product complaints and collaborate with relevant departments for investigation and resolution.

Kenntnisse

QA in pharma

GMP knowledge

Batch record review

Deviation management

Change control

Auditing

English proficiency

MS Office

Quality management software

Ausbildung

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

Tools

Quality management software

MS Office Suite

Jobbeschreibung

Placements24 has partnered with a reputable pharmaceutical company in Paarl, Western Cape, to recruit a diligent Quality Assurance Specialist. The role focuses on ensuring products meet quality, safety, and regulatory standards through batch record reviews, deviation management, change control, and internal audits.

The successful candidate will possess a Bachelor's degree in a life science, at least 3 years' QA/QC experience in pharma, and a strong GMP understanding.