Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; Mtubatuba Local Municipality; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Professional development

Job summary

Placements24 is seeking a meticulous Quality Assurance Specialist for a pharmaceutical manufacturing facility in Richards Bay, KwaZulu-Natal. The role focuses on implementing and maintaining QMS, conducting audits, and investigating deviations within a hybrid work model.

Ideal candidates have a Bachelor’s degree in a relevant science and at least 4 years in QA/QC, with strong GMP/regulatory knowledge and excellent documentation and communication skills.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of GMP, regulatory requirements (FDA, SAHPRA), and quality control principles.
• Experience with QMS, CAPA systems, change control, and deviation management.
• Proficiency in conducting risk assessments and root cause analysis.
• Excellent documentation, communication, and interpersonal skills.
• Ability to work effectively both independently and as part of a team.
• Detail-oriented with strong problem-solving abilities.
• Experience with auditing and regulatory inspections is highly desirable.

Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with cGMP and other relevant standards.
• Conduct internal and external audits of manufacturing processes, facilities, and suppliers to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and ensure the site is prepared for audits.
• Develop and deliver quality training programs to manufacturing and other relevant personnel.
• Monitor key quality metrics and prepare reports for management review.
• Contribute to process improvement initiatives to enhance product quality and manufacturing efficiency.

Skills

GMP knowledge

QMS & CAPA

Audit experience

Documentation

Risk assessment

Regulatory knowledge

Communication skills

Teamwork

Education

Bachelor's degree in Pharmacy, Chemistry, Biology

Job description

About the Role

Our client, a prominent player in the pharmaceutical manufacturing sector, is seeking a meticulous and dedicated Quality Assurance Specialist for their facility in **Richards Bay, KwaZulu-Natal**. This role is fundamental to ensuring that all manufactured pharmaceutical products meet stringent quality standards and comply with regulatory requirements. The Specialist will be responsible for implementing and maintaining quality systems, conducting audits, and investigating deviations. This position offers a hybrid work model, allowing for flexibility while ensuring essential on-site presence for critical quality operations. Join a company that prioritizes quality and safety, contributing to the production of life-saving medicines.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with cGMP and other relevant regulatory standards.
• Conduct internal and external audits of manufacturing processes, facilities, and suppliers to ensure compliance.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and ensure the site is prepared for audits.
• Develop and deliver quality training programs to manufacturing and other relevant personnel.
• Monitor key quality metrics and prepare reports for management review.
• Contribute to process improvement initiatives to enhance product quality and manufacturing efficiency.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 4 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• Strong understanding of Good Manufacturing Practices (GMP), regulatory requirements (e.g., FDA, SAHPRA), and quality control principles.
• Experience with QMS, CAPA systems, change control, and deviation management.
• Proficiency in conducting risk assessments and root cause analysis.
• Excellent documentation, communication, and interpersonal skills.
• Ability to work effectively both independently and as part of a team.
• Detail-oriented with strong problem-solving abilities.
• Experience with auditing and regulatory inspections is highly desirable.

Benefits

Our client offers a competitive salary commensurate with experience, comprehensive health insurance, retirement benefits, and opportunities for professional development and training. The hybrid work arrangement provides flexibility for employees in **Richards Bay, KwaZulu-Natal**, while ensuring the critical oversight required for quality assurance in pharmaceutical manufacturing. This role presents a significant opportunity to contribute to a company dedicated to producing high-quality pharmaceutical products.