Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; Stellenbosch; Vor Ort; ZAR 360.000 - 540.000; Vollzeit

Benefits dieser Stelle

Health Benefits

Retirement Fund

Professional Development

Competitive Salary

Zusammenfassung

Placements24 is seeking a meticulous Quality Assurance Specialist for an on-site role in Paarl, Western Cape. You will review quality documentation, participate in audits, investigate deviations, and contribute to the QMS.

Ideal candidates hold a Bachelor's in Pharmacy, Chemistry, Biotechnology or related field with at least 3 years in pharmaceutical QA. Strong GMP knowledge, attention to detail and collaboration within teams are essential.

Qualifikationen

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology or related scientific discipline.
• Minimum 3 years of QA experience in pharmaceutical or related industries.
• Solid GMP knowledge and regulatory familiarity (SAHPRA).
• Experience with documentation review, deviation management and change control.
• Strong analytical and problem-solving abilities with attention to detail.
• Effective written and verbal communication; ability to work independently and in a team.
• Proficiency in Microsoft Office; familiarity with QA software is advantageous.

Aufgaben

• Review and approve batch records, analytical data and quality documentation.
• Participate in internal/external audits, inspections and regulatory visits.
• Investigate deviations, non-conformances and OOS results; implement CAPA.
• Assist in qualification and validation of equipment, processes and methods.
• Develop and maintain SOPs and work instructions.
• Monitor processes for GMP adherence and quality standards.
• Manage change controls and assess impact on product quality.
• Conduct training on quality systems and GMP compliance.
• Analyze quality metrics to identify trends and improvements.
• Support release of finished products meeting quality requirements.

Kenntnisse

GMP Knowledge

Documentation Review

Deviation Management

Change Control

Analytical Skills

Communication Skills

MS Office

QA Software

Auditing

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, Biotechnology

Tools

Quality Management Software

Jobbeschreibung

About the Role

Our client, a reputable pharmaceutical manufacturer, is seeking a meticulous and proactive Quality Assurance Specialist to join their dedicated team. This role is essential for ensuring that all pharmaceutical products manufactured meet the highest standards of quality, safety, and efficacy. Located in Paarl, Western Cape, the successful candidate will play a critical role in maintaining compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements. You will be responsible for reviewing and approving documentation, participating in audits, investigating deviations, and contributing to the continuous improvement of the quality management system. The ideal candidate possesses a strong understanding of QA principles within the pharmaceutical industry and a keen eye for detail. This is a vital on-site role that requires active participation in manufacturing and quality operations.

Key Responsibilities

• Review and approve manufacturing batch records, analytical data, and other quality-related documentation.
• Participate in internal and external audits, inspections, and regulatory visits.
• Investigate deviations, non-conformances, and out-of-specification (OOS) results, determining root causes and implementing CAPA plans.
• Assist in the qualification and validation of equipment, processes, and analytical methods.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions.
• Monitor manufacturing processes to ensure adherence to GMP and quality standards.
• Manage change control processes, assessing the impact of proposed changes on product quality.
• Conduct training sessions for personnel on quality systems and GMP compliance.
• Compile and analyze quality metrics to identify trends and areas for improvement.
• Support the release of finished products by ensuring all quality requirements have been met.
• Contribute to the maintenance and improvement of the overall Quality Management System (QMS).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or related industry (e.g., medical devices, biologics).
• Solid understanding of GMP guidelines and regulatory requirements (e.g., SAHPRA).
• Experience with documentation review, deviation management, and change control processes.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Effective written and verbal communication skills.
• Ability to work independently and collaboratively within a team environment.
• Proficiency in Microsoft Office Suite and familiarity with quality management software is advantageous.
• Experience in an auditing role is a plus.
• Commitment to quality and regulatory compliance.

Benefits

Our client offers a competitive salary, comprehensive health benefits, retirement fund contributions, and opportunities for professional development. This position in Paarl, Western Cape provides the chance to contribute to a critical function within a stable and growing pharmaceutical company. You will be part of a team focused on upholding the highest standards of quality and making a tangible impact on patient safety. We believe in supporting our employees' career growth and offer ongoing training to enhance skills and knowledge. Join us to build a rewarding career in pharmaceutical quality assurance.