Quality Assurance Specialist - Pharmaceutical Grade

Placements24; Kimberley; Hybrid; CAD 36,000 - 56,000; Full time

Benefits offered by this job

Competitive compensation

Health benefits

Professional growth opportunities

Job summary

Placements24 is assisting a growing pharmaceutical manufacturer in Kimberley, ZA, seeking a meticulous Quality Assurance Specialist for a hybrid role overseeing GMP-compliant QA systems.

You will develop, implement, and maintain QMS, conduct audits, review batch records and CAPAs, and collaborate with R&D, production, and regulatory teams to ensure product quality and regulatory compliance. Strong attention to detail and communication skills are essential.

Qualifications

• Bachelor’s degree in a life science field.
• Minimum 3 years of QA experience in pharma or medical devices.
• In-depth GMP, ICH knowledge and regulatory requirements.
• Experience with QMS, CAPA and change control.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication.

Responsibilities

• Develop, implement, and maintain the QMS.
• Conduct internal audits of manufacturing processes and documentation.
• Review/approve batch records, validation protocols and change controls.
• Investigate deviations, non-conformances, and CAPAs.
• Participate in external audits by regulators and customers.
• Train personnel on QA procedures and GMP principles.
• Monitor quality metrics and report to management.
• Collaborate with R&D, production, and regulatory teams.

Skills

Quality Assurance

GMP/ICH

CAPA

QMS

Audits

Documentation

Analytical

Cross-functional teamwork

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or life science

Tools

Quality management software

Job description

About the Role

Our client, a growing pharmaceutical manufacturer located in Kimberley, Northern Cape, ZA , is seeking a meticulous Quality Assurance Specialist . This hybrid role is critical for ensuring that our products meet the highest standards of quality and regulatory compliance within the pharmaceutical industry. You will be responsible for developing, implementing, and maintaining quality assurance systems, conducting audits, and ensuring adherence to Good Manufacturing Practices (GMP). The ideal candidate possesses a strong understanding of pharmaceutical quality systems and a keen eye for detail. This position requires a combination of on-site quality oversight and remote documentation review/analysis, offering a balanced work arrangement.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS).


• Ensure compliance with relevant pharmaceutical regulations (e.g., FDA, EMA, local health authorities).


• Conduct internal audits of manufacturing processes, facilities, and documentation.


• Review and approve batch records, validation protocols, and change controls.


• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).


• Participate in external audits conducted by regulatory agencies and customers.


• Train personnel on quality assurance procedures and GMP principles.


• Monitor and analyze quality metrics, providing reports to management.


• Collaborate with R&D, production, and regulatory affairs teams on quality-related matters.


• Stay current with evolving pharmaceutical regulations and industry best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.


• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry.


• In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.


• Experience with Quality Management Systems, CAPA processes, and change control.


• Strong analytical and problem-solving skills.


• Excellent written and verbal communication skills.


• Proficiency in using quality management software and standard office applications.


• Ability to work effectively both independently and as part of a cross-functional team.


• Detail-oriented with a strong commitment to accuracy.


• Flexibility to work a hybrid schedule, including on-site presence in Kimberley, Northern Cape, ZA for audits and process oversight, and remote tasks.

Benefits

Our client offers a competitive salary, comprehensive health and retirement benefits, paid time off, and opportunities for professional growth within a growing pharmaceutical company. Employees contribute to the production of life-saving medications in a quality-focused environment. We provide ongoing training and development to keep our team at the forefront of pharmaceutical quality standards. This hybrid role offers flexibility and essential on-site engagement.