Quality Assurance Specialist - Remote Compliance

Placements24; Durban; Hybrid; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Remote work from home

Competitive salary with bonuses

Health insurance & retirement plan

Job summary

Placements24 seeks a dedicated Quality Assurance Specialist to join a global pharmaceutical manufacturer. This fully remote role allows you to contribute from your home office while upholding GMP, QMS, and CAPA standards.

You will conduct internal audits, review batch records, manage deviations, and collaborate with R&D, regulatory and production to ensure product integrity and patient safety. Strong data integrity and documentation skills are essential.

Qualifications

• Bachelor's degree in a life science field (Pharmacy/Chemistry/Biotech) as required.
• Minimum 3 years' QA experience in pharma/medical device industry.
• Strong knowledge of GMP and regulatory guidelines.
• Experience with QMS, audits, CAPA and change control procedures.
• Excellent analytical, problem-solving and documentation skills.
• Solid data integrity understanding and attention to detail.
• Ability to work independently and remotely with strong communication.

Responsibilities

• Develop, implement and maintain QMS in line with GMP/ISO.
• Conduct internal audits and support regulatory/customer audits.
• Review/approve batch records and validation protocols.
• Investigate deviations, non-conformances and CAPA actions.
• Participate in risk assessments and change control processes.
• Monitor quality metrics and provide management reports.
• Train personnel on QA procedures and compliance requirements.
• Collaborate with R&D, production and regulatory affairs across product life cycle.
• Stay up-to-date with evolving regulatory landscapes and best practices.

Skills

Quality Assurance

Audits

CAPA

Documentation

Data integrity

Remote work

Education

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

Tools

MS Office

Quality Management Software

Job description

About the Role

Our client, a global leader in the pharmaceutical manufacturing space, is seeking a dedicated and meticulous Quality Assurance Specialist to join their esteemed team. This position is fully remote, allowing you to contribute significantly to our client's commitment to excellence from your own home office. You will play a critical role in developing, implementing, and maintaining the company's quality management systems, ensuring all products meet stringent regulatory and internal standards. The ideal candidate will have a strong background in pharmaceutical quality assurance, a keen eye for detail, and a passion for ensuring product integrity and patient safety. This is an exciting opportunity to leverage your expertise in a crucial function within a highly respected organization.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with regulatory requirements (e.g., GMP, ISO).
• Conduct internal audits and support external audits by regulatory agencies and customers.
• Review and approve batch records, validation protocols, and other critical documentation.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA).
• Participate in risk assessments and change control processes.
• Monitor and analyze quality metrics and trends, providing reports to management.
• Train personnel on quality assurance procedures and compliance requirements.
• Collaborate with R&D, production, and regulatory affairs departments to ensure quality standards are met throughout the product lifecycle.
• Stay up-to-date with evolving regulatory landscapes and industry best practices.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, 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 Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
• Proven experience with QMS, audits, CAPA, and change control procedures.
• Excellent analytical, problem-solving, and documentation skills.
• Strong understanding of data integrity principles.
• Effective communication and interpersonal skills, with the ability to work independently and remotely.
• Proficiency in MS Office Suite and experience with quality management software.
• Must be able to work independently and manage time effectively in a remote setting.

Benefits

• Our client is committed to offering a compelling package for its remote employees. This includes a competitive annual salary, performance-based bonuses, and opportunities for professional development and certifications.
• You will benefit from the flexibility of working from home, with support for home office setup.
• Additional benefits include comprehensive health insurance coverage, a retirement savings plan, and access to virtual employee assistance programs.

Join a team dedicated to making a difference in global health.