Senior Pharmaceutical Quality Assurance Specialist

Placements24; Kempton Park; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive benefits package

Hybrid work model

Professional development opportunities

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist in Tembisa, Gauteng. The role combines on-site QA oversight with remote documentation work, ensuring GMP compliance, batch record integrity, and CAPA implementation.

You will conduct internal audits, support external inspections, and drive continuous improvement across quality systems and SOPs, with collaboration across cross-functional teams.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field.
• Minimum of 5 years in pharmaceutical Quality Assurance or Quality Control.
• Thorough understanding of GMP, ICH guidelines, and other regulatory requirements.
• Proven experience with batch record review, deviation management, CAPA, and change control systems.
• Experience with internal and external audits is essential.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent documentation and technical writing abilities.

Responsibilities

• Review and approve batch production records, analytical data, and release documentation to ensure compliance with specifications and regulatory requirements.
• Manage and investigate deviations, OOS results, and customer complaints, implementing CAPAs.
• Oversee the change control process, assess impact on product quality and regulatory compliance.
• Conduct internal audits and participate in external regulatory inspections, ensuring readiness and addressing findings.
• Develop, review, and implement Quality Assurance procedures and SOPs.
• Monitor manufacturing processes for GMP compliance.
• Participate in vendor qualification and auditing processes.
• Train personnel on quality system requirements and GMP principles.
• Maintain quality metrics and generate reports for management review.
• Support product lifecycle management and continuous improvement initiatives.

Skills

QA expertise

GMP/ICH knowledge

Batch record review

Deviation management

CAPA

Change control

Audits (internal/external)

Data analysis

Technical writing

Quality software

Cross-functional skills

Communication skills

Education

Bachelor's degree in Pharmacy/Science

Tools

Quality management software

MS Office

Job description

About the Role

Our client, a respected player in the pharmaceutical manufacturing landscape, is looking for a diligent and experienced Senior Pharmaceutical Quality Assurance Specialist to join their team in Tembisa, Gauteng. This integral role supports the company’s commitment to maintaining the highest standards of product quality, safety, and regulatory compliance. The specialist will be involved in a wide range of QA activities, including batch record review, deviation management, change control, internal audits, and ensuring adherence to Good Manufacturing Practices (GMP). This hybrid position allows for essential on-site laboratory and production oversight, complemented by flexible remote work for documentation review and data analysis. Join a company dedicated to pharmaceutical excellence and contribute to ensuring the integrity of life-saving medications. The ideal candidate possesses a strong understanding of quality systems, regulatory requirements, and a proactive approach to quality assurance in the pharmaceutical industry.

Key Responsibilities

• Review and approve batch production records, analytical data, and release documentation to ensure compliance with specifications and regulatory requirements.
• Manage and investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Oversee the change control process, assessing the impact of proposed changes on product quality and regulatory compliance.
• Conduct internal audits and participate in external regulatory inspections, ensuring readiness and addressing findings.
• Develop, review, and implement Quality Assurance procedures and SOPs.
• Monitor and assess manufacturing processes for compliance with GMP and other relevant regulations.
• Participate in vendor qualification and auditing processes.
• Train personnel on quality system requirements and GMP principles.
• Maintain quality metrics and generate reports for management review.
• Support product lifecycle management and continuous improvement initiatives.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Thorough understanding of GMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience with batch record review, deviation management, CAPA, and change control systems.
• Experience with internal and external audits is essential.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent documentation and technical writing abilities.
• Proficiency in quality management software and standard office applications.
• Effective communication and interpersonal skills for cross-functional collaboration.
• Ability to perform effectively in a hybrid work setting, balancing on-site QA duties with remote administrative tasks in Tembisa, Gauteng.

Benefits

• Competitive annual salary of R .
• Comprehensive medical aid, retirement fund, and life insurance benefits.
• Opportunities for professional development and specialized training.
• A stable and supportive work environment within a growing pharmaceutical company.
• Access to modern quality systems and technologies.
• Generous paid time off and company holidays.
• Employee assistance program for well-being.
• Potential for career advancement within the QA department.
• Study leave for relevant certifications.
• Performance recognition awards.