Pharmaceutical Quality Assurance Specialist

Placements24; Kempton Park; Hybrid; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Hybrid work model

Comprehensive medical, dental, and vis

Bonuses potential

Professional growth opportunities

Training programs and workshops

Job summary

Placements24 is seeking a meticulous Pharmaceutical Quality Assurance Specialist to join their team in Tembisa. This hybrid role focuses on maintaining high standards of quality and compliance across manufacturing processes, developing robust quality systems, and ensuring regulatory adherence.

The position emphasizes collaboration with production, R&D, and regulatory affairs, handling audits, CAPAs, and batch documentation to safeguard product quality and patient safety.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 3–5 years' experience in QA or QC in the pharmaceutical industry.
• In-depth knowledge of GMP, ICH guidelines and quality systems.
• Experience with documentation review, audit procedures, and CAPA management.
• Strong analytical and problem-solving skills with excellent communication.

Responsibilities

• Develop and implement QA policies, procedures, and systems to ensure GMP compliance.
• Conduct internal audits and inspections of manufacturing processes, facilities, and documentation.
• Review and approve batch records, validation protocols, and change control documents.
• Investigate deviations, customer complaints, and OOS results; implement CAPAs.
• Collaborate with production, R&D, and regulatory affairs to ensure product quality.
• Participate in external audits by regulatory authorities and customers.

Skills

Quality Assurance

GMP knowledge

Auditing

CAPA management

Analytical skills

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Job description

About the Role

Our client is seeking a meticulous Pharmaceutical Quality Assurance Specialist to join their dynamic team in Tembisa. This hybrid role requires a proactive individual dedicated to ensuring the highest standards of quality and compliance across all pharmaceutical manufacturing processes. You will be instrumental in developing, implementing, and maintaining robust quality systems that adhere to regulatory requirements. This position is crucial for upholding the integrity and safety of our pharmaceutical products, contributing directly to patient well-being and the company's reputation for excellence in a structured, collaborative environment.

Key Responsibilities

• Develop and implement Quality Assurance policies, procedures, and systems to ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
• Conduct internal audits and inspections of manufacturing processes, facilities, and documentation to identify deviations and areas for improvement.
• Review and approve batch records, validation protocols, and change control documents.
• Investigate deviations, customer complaints, and Out-of-Specification (OOS) results, implementing corrective and preventive actions (CAPAs).
• Collaborate with production, R&D, and regulatory affairs teams to ensure product quality and compliance throughout the product lifecycle.
• Participate in external audits by regulatory authorities and customers.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• In-depth knowledge of GMP regulations, ICH guidelines, and pharmaceutical quality systems.
• Experience with documentation review, audit procedures, and CAPA management.
• Strong analytical and problem-solving skills with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented setting.

Benefits

• Competitive annual salary and potential for bonuses.
• Comprehensive medical, dental, and vision insurance.
• Opportunities for professional growth and development within the pharmaceutical quality sector.
• Hybrid work model offering flexibility between home and office.
• Company-sponsored training programs and workshops.