Senior Pharmaceutical Quality Assurance Specialist

Placements24; Pietermaritzburg; Hybrid; ZAR 900,000 - 1,100,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Professional development

Pension fund contributions

Generous leave

Collaborative team environment

Job summary

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist to join our client’s team in Pietermaritzburg. The role emphasizes upholding GMP standards, leading QMS initiatives and driving improvement across manufacturing processes.

The ideal candidate will bring 5–7 years of QA experience in pharma, deep regulatory knowledge (SAHPRA, FDA, EMA) and a proven track record in audits and CAPA implementation.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology or related life science field is required.
• Minimum 5–7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Strong knowledge of GMP and regulatory guidelines (SAHPRA, FDA, EMA).
• Experience in conducting audits, managing deviations, and implementing CAPA systems.
• Excellent analytical, problem-solving and decision-making abilities.

Responsibilities

• Develop, implement and maintain Quality Management Systems (QMS) per GMP/ISO standards.
• Conduct internal audits and inspections of facilities, processes and documentation.
• Investigate deviations and CAPAs and determine root causes.
• Review batch records, validation protocols and technical reports for compliance.
• Collaborate with production, R&D and regulatory affairs to resolve quality issues.

Skills

GMP knowledge

Audits

CAPA implementation

Analytical skills

Communication skills

Problem-solving

Team collaboration

Education

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

Master's degree advantageous

Tools

QMS software

MS Office

Job description

About the Role

Our client, a leading name in the pharmaceutical sector, is seeking to expand its dedicated team with a highly skilled and experienced Senior Pharmaceutical Quality Assurance Specialist. This pivotal role is based in the vibrant city of Pietermaritzburg, KwaZulu-Natal , and offers a unique opportunity to contribute to the development and maintenance of stringent quality standards within a dynamic and innovative environment. The successful candidate will play a crucial part in ensuring that all pharmaceutical products meet and exceed regulatory requirements and internal quality benchmarks. This position demands a proactive approach to quality management and a deep understanding of the pharmaceutical manufacturing processes. We are looking for an individual who is passionate about quality and possesses the analytical skills to uphold the highest standards in every aspect of their work. This role is integral to our client's commitment to delivering safe and effective pharmaceutical solutions to the market, making it a rewarding position for a dedicated professional.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with national and international pharmaceutical regulations (e.g., GMP, ISO).
• Conduct regular internal audits and inspections of manufacturing facilities, processes, and documentation to identify areas for improvement and ensure compliance.
• Investigate deviations, non-conformances, and customer complaints, determining root causes and implementing effective corrective and preventive actions (CAPAs).
• Review and approve batch records, validation protocols, and technical reports to ensure accuracy and compliance.
• Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to resolve quality-related issues and promote a quality-focused culture.
• Monitor industry trends and regulatory updates, proactively adapting QMS to maintain compliance and enhance product quality.
• Train and mentor junior QA personnel, fostering their professional development and ensuring consistent application of quality standards.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field. A Master's degree is an advantage.
• Minimum of 5-7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), regulatory guidelines (e.g., SAHPRA, FDA, EMA), and quality management principles.
• Proven experience in conducting audits, managing deviations, and implementing CAPA systems.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with diverse teams.
• Proficiency in relevant software applications, including QMS software and standard office suites.
• Demonstrated ability to work independently and as part of a team in a fast-paced environment.

Benefits

• Competitive annual salary commensurate with experience and qualifications.
• Comprehensive health insurance package including medical and dental coverage.
• Opportunities for professional development, including workshops, conferences, and further certifications.
• Generous annual leave allowance.
• Pension fund contributions.
• A supportive and collaborative work environment within a growing pharmaceutical company.
• The chance to make a significant impact on product quality and patient safety.