Quality Assurance Specialist - Pharmaceutical Grade

Placements24; Kimberley; Hybrid; CAD 35,000 - 54,000; Full time

Benefits offered by this job

Competitive salary

Health and retirement benefits

Professional growth opportunities

Hybrid role

Job summary

Placements24 is seeking a meticulous Quality Assurance Specialist for a growing pharmaceutical manufacturer in Kimberley, South Africa. The role combines on-site audits and remote document reviews to ensure GMP compliance and robust quality systems.

You will develop and maintain the QMS, perform internal audits, review batch records, CAPAs, and participate in external audits. Strong knowledge of GMP, ICH, and regulatory requirements is essential, along with excellent communication and teamwork.

Qualifications

• 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 regulatory requirements.
• Experience with Quality Management Systems, CAPA, and change control.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.

Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS).
• Ensure compliance with relevant pharmaceutical regulations (FDA, EMA, local 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 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 matters.
• Stay current with evolving pharmaceutical regulations and industry best practices.

Skills

GMP knowledge

ICH guidelines

CAPA processes

Change control

Analytical skills

Communication skills

QMS

Cross-functional teamwork

Detail oriented

Independent work

Education

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

Tools

QMS software

Microsoft Office

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.