Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; Noord-Kaap; Híbrido; CAD 51 000 - 76 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Medical aid

Retirement fund

Training & certifications

Resumo da oferta

Placements24 is assisting a reputable pharmaceutical manufacturer in Kimberley, seeking a meticulous Quality Assurance Specialist to ensure that all manufacturing processes and products meet GMP and regulatory quality standards.

The role requires strong knowledge of GMP, regulatory compliance, quality systems, and CAPA management, with responsibility for QMS development, internal audits, batch record reviews, and continuous improvement across the site. On-site with potential for hybrid work.

Qualificações

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
• Minimum of 5 years of experience in Quality Assurance within pharma/biotech.
• Strong knowledge of GMP, ICH guidelines and regulatory requirements.
• Experience in internal audits and CAPA systems.
• Knowledge of quality systems, document control and batch record review.

Responsabilidades

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with pharmaceutical regulations.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure adherence to GMP.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, OOS results, and customer complaints, implementing CAPAs.
• Participate in external audits by regulatory agencies and customers.
• Monitor and ensure compliance with pharmaceutical quality standards and guidelines.
• Train personnel on quality assurance procedures and GMP requirements.
• Manage change control processes for manufacturing operations.
• Collaborate with cross-functional teams to resolve quality-related issues.
• Contribute to continuous improvement initiatives within the quality assurance department.

Conhecimentos

GMP knowledge

Auditing

CAPA management

Documentation control

Batch record review

Analytical thinking

Problem solving

Communication skills

Team collaboration

Detail-oriented

Formação académica

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

Ferramentas

MS Office Suite

Descrição da oferta de emprego

About the Role

Our client, a reputable pharmaceutical manufacturer, is seeking a meticulous Quality Assurance Specialist to join their team in Kimberley . This role is pivotal in ensuring that all manufacturing processes and products meet the stringent regulatory standards and quality requirements of the pharmaceutical industry. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), quality systems, and regulatory compliance. This position offers a significant opportunity to contribute to the production of life-saving medicines and uphold the highest quality standards within the Northern Cape pharmaceutical sector.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with pharmaceutical regulations.
• Conduct internal audits of manufacturing processes, documentation, and facilities to ensure adherence to GMP.
• Review and approve batch records, validation protocols, and other critical quality documents.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventative actions (CAPAs).
• Participate in external audits by regulatory agencies and customers.
• Monitor and ensure compliance with all relevant pharmaceutical quality standards and guidelines.
• Train personnel on quality assurance procedures and GMP requirements.
• Manage change control processes for manufacturing operations.
• Collaborate with cross-functional teams to resolve quality-related issues.
• Contribute to continuous improvement initiatives within the quality assurance department.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
• Proven experience in conducting internal audits and managing CAPA systems.
• Strong understanding of quality systems, document control, and batch record review.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Detail-oriented with a high level of accuracy.
• Proficiency in MS Office Suite.
• Must be willing to work on-site in Kimberley , Northern Cape, with potential for hybrid arrangements.

Benefits

• Our client offers a competitive salary, comprehensive medical aid, a retirement fund, and potential performance-based bonuses.
• The company provides excellent opportunities for professional development, including advanced training, certifications, and exposure to cutting-edge pharmaceutical quality practices.
• You will join a highly regulated and quality-focused environment, contributing to the well-being of patients.
• This role in Kimberley offers a chance to advance your career in pharmaceutical quality assurance with a respected organization.