Pharmaceutical Quality Assurance Specialist - Soweto

Placements24; Soweto; On-site; ZAR 420,000 - 720,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Retirement fund benefits

Professional growth opportunities

Job summary

Placements24 is seeking a Pharmaceutical Quality Assurance Specialist in Soweto to ensure products meet GMP standards and regulatory requirements. You will implement the QMS, conduct audits, review batch records, and manage deviations and CAPAs to sustain drug safety and quality.

The ideal candidate has a pharmacy/related degree and at least 3 years of QA/QC experience, with strong analytical and documentation skills.

Qualifications

• Bachelor's degree in Pharmacy or a related scientific field.
• Proven experience in pharmaceutical QA/QC.
• Strong understanding of GMP and regulatory requirements.
• Experience with QMS, document control, batch review.
• Proficiency in deviation investigations and CAPA management.
• Excellent analytical, documentation and communication skills.

Responsibilities

• Support the implementation and maintenance of the Quality Management System (QMS).
• Conduct internal audits and participate in external audits (regulatory inspections, customer audits).
• Review and approve batch manufacturing records to ensure compliance with procedures.
• Manage deviations, non-conformances and customer complaints; ensure timely resolution.
• Implement and track CAPAs to address quality issues.
• Ensure GMP compliance and regulatory alignment.
• Participate in change control activities and risk assessments.
• Assist in qualification and validation of equipment and processes.
• Develop and deliver quality training to relevant personnel.
• Monitor and report on KPIs.

Skills

GMP Knowledge

CAPA Management

Deviation Investigation

Internal Audits

Document Control

Data Analysis

Regulatory Compliance

MS Office

Education

Bachelor's degree in Pharmacy or related field

Tools

MS Office

Quality Management Software

Job description

About the Role

Our client, a reputable pharmaceutical company, is seeking a detail-oriented and proactive Pharmaceutical Quality Assurance Specialist to join their team in Soweto . This role is essential in ensuring that all pharmaceutical products meet the highest standards of quality and comply with regulatory requirements. You will be responsible for implementing and maintaining the Quality Management System (QMS), conducting internal audits, reviewing batch records, and managing deviations and CAPAs. The ideal candidate will possess a strong understanding of GMP, a keen eye for detail, and excellent analytical and documentation skills. This is a great opportunity to contribute to the safety and efficacy of medicines. We are committed to upholding stringent quality standards and are looking for individuals who share this dedication.

Key Responsibilities

• Support the implementation and maintenance of the company's Quality Management System (QMS).
• Conduct internal audits and participate in external audits (e.g., regulatory inspections, customer audits).
• Review and approve batch manufacturing records, ensuring compliance with approved procedures.
• Manage and investigate deviations, non-conformances, and customer complaints, ensuring timely and effective resolution.
• Implement and track Corrective and Preventive Actions (CAPAs) to address quality issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Participate in change control activities and risk assessments.
• Assist in the qualification and validation of equipment and processes.
• Develop and deliver quality training to relevant personnel.
• Monitor and report on key quality performance indicators (KPIs).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• Minimum of 3 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Thorough understanding of GMP principles and pharmaceutical regulatory requirements.
• Experience with Quality Management Systems, document control, and batch record review.
• Proficiency in investigation of deviations, root cause analysis, and CAPA management.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple tasks, and meet deadlines.
• Familiarity with audit processes (internal and external) is essential.
• Computer proficiency, including experience with MS Office and quality management software.

Benefits

• Our client offers a competitive salary, comprehensive medical aid, retirement fund benefits, and opportunities for professional growth and development within the pharmaceutical industry.
• This role, located in Soweto , is integral to ensuring product quality and patient safety.
• Join a dedicated team focused on maintaining the highest standards of pharmaceutical excellence.
• Our client provides a supportive work environment where quality is paramount and employee contributions are valued.