Quality Assurance Specialist (Pharmaceuticals)

Placements24; Queenstown; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Medical aid

Performance bonuses

Job summary

Placements24 partners with a leading pharmaceutical company in Queenstown to recruit a Quality Assurance Specialist. This office-based role focuses on developing, implementing, and maintaining QMS to ensure GMP/ICH compliance and product quality.

You will conduct internal audits, manage deviations and CAPAs, train staff, and support production and labs while staying current with regulatory trends. The position offers a competitive salary and benefits.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• Minimum of 4 years' experience in Quality Assurance within pharma or biotech.
• In-depth knowledge of GMP, GLP, and regulatory guidelines (SAHPRA, FDA, EMA).
• Experience in internal audits, deviations, and CAPA implementation.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent documentation and report-writing abilities.
• Proficiency in MS Office and familiarity with QMS software.
• Ability to work effectively in a team and independently in an office setting.

Responsibilities

• Develop, implement, and maintain QMS per GMP/ICH guidelines.
• Conduct internal audits and inspections for compliance with procedures and regulatory requirements.
• Review and approve batch records, validation protocols, and related documentation.
• Investigate deviations, OOS results, and customer complaints; implement CAPAs.
• Participate in external audits and inspections by regulators and clients.
• Develop and deliver training on QA principles and procedures.
• Monitor quality control processes and guide production and lab teams.
• Stay up-to-date with evolving regulatory requirements and best practices.
• Contribute to continuous improvement of quality systems and processes.

Skills

Quality Assurance

Auditing

CAPA management

Analytical skills

Documentation

MS Office

QMS software

Regulatory knowledge

Problem solving

Attention to detail

Education

Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or related field

Tools

QMS software

MS Office

Job description

About the Role

Our client, a prominent recruitment consultancy, is seeking a meticulous and experienced Quality Assurance Specialist to join a leading pharmaceutical company based in Queenstown, Eastern Cape . This role is critical in ensuring that all products and processes meet stringent quality standards and comply with regulatory requirements. You will be involved in developing, implementing, and maintaining quality management systems. This position is office-based, providing direct engagement with laboratory and production teams, fostering a collaborative and quality-focused environment. The ideal candidate will possess a strong background in pharmaceutical quality assurance, exceptional attention to detail, and a commitment to upholding the highest industry standards. Our client is dedicated to placing top talent within the life sciences sector, ensuring compliance and excellence.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with pharmaceutical industry standards (e.g., GMP, ICH guidelines).
• Conduct internal audits and inspections to ensure compliance with established quality procedures and regulatory requirements.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPAs).
• Participate in external audits and inspections by regulatory authorities and clients.
• Develop and deliver training programs on quality assurance principles and procedures to relevant personnel.
• Monitor quality control processes and provide guidance to production and laboratory teams.
• Stay up-to-date with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
• Contribute to the continuous improvement of quality systems and processes.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field.
• A minimum of 4 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., SAHPRA, FDA, EMA).
• Proven experience in conducting internal audits, managing deviations, and implementing CAPAs.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent documentation and report-writing abilities.
• Proficiency in MS Office Suite and familiarity with QMS software.
• Ability to work effectively in a team and independently in an office-based setting.
• Strong attention to detail and commitment to quality excellence.

Benefits

This office-based role offers a competitive salary and benefits package, including medical aid and potential performance bonuses. You will join a reputable pharmaceutical company and work within a dedicated quality assurance team. Opportunities for professional development and further specialization in pharmaceutical quality are available. Our client provides access to ongoing training and resources to ensure you remain at the forefront of regulatory compliance. Be part of a critical function that ensures the safety and efficacy of pharmaceutical products in Queenstown . This role is for a professional committed to maintaining the highest standards of quality and compliance in a vital industry.