Quality Assurance Specialist (Pharmaceuticals)

Placements24; Pretoria; Hybrid; ZAR 420,000 - 600,000; Full time

Benefits offered by this job

Home office stipend

Remote work flexibility

Learning and development opportunities

Paid time off and holidays

Retirement savings plan with company"

Job summary

Placements24 is seeking a meticulous Quality Assurance Specialist to join a fully remote team in the pharmaceutical sector. You will develop and maintain the QMS, conduct supplier and internal audits, review documentation, and drive CAPAs to ensure regulatory compliance and product quality.

The role requires a Bachelor’s degree in a related field and 3–5 years of QA/QC experience, with strong knowledge of cGMP, FDA guidelines, and ICH.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 3–5 years of experience in QA/QC in pharma.
• In-depth knowledge of cGMP, FDA guidelines, and ICH principles.
• Experience with auditing techniques, QMS implementation, and deviation investigations.
• Proficiency in document control and change management processes.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization.
• Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Detail-oriented with a commitment to upholding the highest quality standards.
• Familiarity with validation principles (process, cleaning, equipment) is a plus.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ISO).
• Conduct internal and external (supplier) audits to assess compliance and identify areas for improvement.
• Review and approve quality-related documentation, including batch records, SOPs, and validation protocols.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and audits by health authorities, acting as a primary point of contact.
• Monitor and analyze quality metrics, preparing reports for management review.
• Provide training to personnel on quality standards, procedures, and regulatory requirements.
• Collaborate with manufacturing, R&D, and other departments to ensure quality is integrated throughout the product lifecycle.
• Stay updated on current Good Manufacturing Practices (cGMP) and other relevant pharmaceutical regulations.
• Contribute to risk management activities and process improvement initiatives.

Skills

GMP

ISO

Auditing

QMS

CAPA

Documentation control

Regulatory requirements

Quality assurance

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Job description

About the Role

Our client, a significant player in the global pharmaceutical industry, is looking for a meticulous and proactive Quality Assurance Specialist to join their fully remote team. This role is essential for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements. As a remote team member, you will be instrumental in developing, implementing, and maintaining the Quality Management System (QMS), conducting audits, and ensuring compliance across various operational areas. This is an exceptional opportunity to contribute to public health by upholding product integrity, working within a flexible, remote-first work environment that values collaboration and efficiency. You will engage with diverse departments, providing expert guidance on quality-related matters and driving continuous improvement initiatives from your designated workspace. The ideal candidate possesses a keen eye for detail and a comprehensive understanding of pharmaceutical quality standards.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory standards (e.g., GMP, ISO).
• Conduct internal and external (supplier) audits to assess compliance and identify areas for improvement.
• Review and approve quality-related documentation, including batch records, SOPs, and validation protocols.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in regulatory inspections and audits by health authorities, acting as a primary point of contact.
• Monitor and analyze quality metrics, preparing reports for management review.
• Provide training to personnel on quality standards, procedures, and regulatory requirements.
• Collaborate with manufacturing, R&D, and other departments to ensure quality is integrated throughout the product lifecycle.
• Stay updated on current Good Manufacturing Practices (cGMP) and other relevant pharmaceutical regulations.
• Contribute to risk management activities and process improvement initiatives.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
• In-depth knowledge of cGMP regulations, FDA guidelines, and ICH principles.
• Experience with auditing techniques, QMS implementation, and deviation investigations.
• Proficiency in document control and change management processes.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization.
• Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
• Detail-oriented with a commitment to upholding the highest quality standards.
• Familiarity with validation principles (process, cleaning, equipment) is a plus.

Benefits

• Competitive salary and comprehensive benefits package.
• Remote work flexibility with a home office stipend.
• Opportunities for continuous learning and professional development.
• Contribution to meaningful projects impacting global health.
• Work within a supportive and collaborative virtual team environment.
• Generous paid time off and holiday schedule.
• Retirement savings plan with company match.