Remote Pharmaceutical Quality Assurance Specialist

Placements24; East London; Hybrid; ZAR 360.000 - 620.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement savings plan

Paid time off

Zusammenfassung

Placements24 is seeking a meticulous Remote Pharmaceutical Quality Assurance Specialist for a well-established pharma manufacturer. You will uphold GMP, review documents, and support audits from any approved location, contributing to patient safety and product integrity in a remote-first team.

The role emphasizes QMS development, CAPA implementation, deviation investigations, and change control, with opportunities to work independently and collaboratively using digital platforms.

Qualifikationen

• Minimum 3 years of experience in Quality Assurance within pharma.
• Thorough understanding of GMP and regulatory guidelines (ICH, SAHPRA).
• Experience with document control, deviations, CAPA, and change control.

Aufgaben

• Assist in developing and maintaining the QMS.
• Review and approve quality documents (SOPs, batch records, validation protocols).
• Investigate deviations and implement CAPAs, perform root cause analysis.
• Support internal and external audits by regulators and clients.
• Monitor GMP compliance across manufacturing processes and identify improvements.
• Manage change control impact assessments on product quality.
• Review releases of raw materials, packaging components, and finished products.
• Prepare quality metrics and management reports.

Kenntnisse

QA principles

Regulatory compliance

Analytical thinking

Attention to detail

Remote work discipline

Ausbildung

Bachelor's degree in Pharmacy/chemistry/biology or related

Tools

MS Office Suite

Quality Management Software (QMS)

Jobbeschreibung

About the Role

Our client, a well-established pharmaceutical manufacturer, is actively seeking a meticulous and dedicated Remote Pharmaceutical Quality Assurance Specialist to enhance their quality systems. This fully remote role provides an exceptional opportunity to contribute to pharmaceutical quality compliance from any approved location. You will be instrumental in ensuring that all processes and documentation adhere to Good Manufacturing Practices (GMP) and other relevant regulatory standards. The ideal candidate will possess a strong understanding of QA principles, regulatory requirements, and a keen eye for detail. As part of our remote-first team, you will utilize advanced digital platforms for collaboration and document management, ensuring seamless operation. This is a significant chance to join a company focused on producing high-quality pharmaceuticals and to make a direct impact on patient safety and product integrity. You will be a key player in upholding our client's commitment to excellence.

Key Responsibilities

• Assist in the development, implementation, and maintenance of the Quality Management System (QMS).
• Review and approve quality-related documents, including Standard Operating Procedures (SOPs), batch records, and validation protocols.
• Participate in deviation investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPAs).
• Conduct internal audits and support external audits by regulatory agencies and clients.
• Monitor manufacturing processes for GMP compliance and identify areas for improvement.
• Manage change control processes, assessing the impact of proposed changes on product quality.
• Review and release raw materials, packaging components, and finished product batches.
• Maintain quality metrics and prepare reports for management review.
• Ensure compliance with all applicable regulatory requirements and company policies.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical industry.
• Thorough understanding of GMP regulations and guidelines (e.g., ICH, SAHPRA).
• Experience with document control, deviation management, CAPA, and change control processes.
• Familiarity with auditing procedures and hosting inspections.
• Strong analytical and problem-solving skills with excellent attention to detail.
• Ability to work independently, prioritize tasks, and manage time effectively in a remote setting.
• Good written and verbal communication skills.
• Proficiency in MS Office Suite and experience with Quality Management Software (QMS) is desirable.

Benefits

This fully remote role offers a competitive salary and a comprehensive benefits package, including health insurance, retirement savings plans, and paid time off. Our client is dedicated to providing a flexible and supportive remote work environment, equipped with the necessary technology for efficient work. You will have the opportunity to contribute to critical quality assurance functions that ensure the safety and efficacy of pharmaceutical products. This position, conceptually linked to **East London, Eastern Cape**, presents a valuable career opportunity for growth within a reputable pharmaceutical organization committed to its employees' development and well-being.