Remote Quality Assurance Specialist - Pharmaceutical Manufacturing

Placements24; O Mente; A distancia; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Health insurance

Retirement plan

Descripción de la vacante

Placements24 is seeking a Remote Quality Assurance Specialist to join our regulatory compliance team. You will review batch records, investigate deviations, and support regulatory inspections from anywhere in Spain.

The ideal candidate has a life science degree and at least four years in pharmaceutical QA, with strong GMP knowledge and experience with eQMS. In this fully remote role, you will develop SOPs, manage CAPA, and collaborate with manufacturing and validation teams to uphold product

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or life science.
• Minimum 4 years of QA experience in pharma/biopharma manufacturing.
• In-depth GMP knowledge (ICH Q7) and QA systems.
• Experience with batch record review, deviation management, CAPA, change control.
• Auditing experience both internal and external.
• Excellent written and verbal communication.
• Proficiency with eQMS and standard office software.
• Ability to work independently in a remote setting.

Responsabilidades

• Review and approve batch records for GMP compliance.
• Investigate deviations and OOS; implement CAPA.
• Conduct internal audits of processes and quality systems.
• Prepare for regulatory inspections (SAHPRA, FDA, EMA).
• Develop and update SOPs and quality documents.
• Participate in change control; assess impact on quality.
• Maintain quality documentation and records.
• Collaborate remotely with manufacturing, validation, and quality teams.
• Monitor quality metrics and identify trends.
• Contribute to continuous improvement in QA.

Conocimientos

GMP knowledge

Quality assurance

Analytical thinking

Regulatory compliance

Documentation

Problem solving

Remote work

Educación

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

Herramientas

eQMS

Office software

Descripción del empleo

About the Role

Our client, a prominent global pharmaceutical manufacturer, is seeking a dedicated and experienced Remote Quality Assurance Specialist to join their regulatory compliance team. This entirely remote position allows you to contribute to ensuring the highest standards of quality and compliance within pharmaceutical manufacturing operations from anywhere in South Africa. The QA Specialist will be responsible for reviewing and approving batch records, managing deviations, conducting internal audits, and supporting regulatory inspections. The ideal candidate possesses a meticulous eye for detail, a thorough understanding of Good Manufacturing Practices (GMP), and a proven ability to uphold rigorous quality standards in a regulated environment. This is a unique opportunity to leverage your pharmaceutical QA expertise in a flexible, remote work setting.

Key Responsibilities

• Review and approve manufacturing batch records, ensuring completeness and compliance with GMP.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, determining root causes and implementing corrective/preventive actions (CAPA).
• Conduct internal audits of manufacturing processes, documentation, and quality systems.
• Prepare for and support external regulatory inspections (e.g., SAHPRA, FDA, EMA).
• Develop and update Standard Operating Procedures (SOPs) and other quality-related documents.
• Participate in change control activities, assessing the impact of proposed changes on product quality.
• Maintain quality documentation and records in a compliant manner.
• Collaborate remotely with manufacturing, validation, and other quality-related departments.
• Monitor quality metrics and identify trends that may impact product quality or compliance.
• Contribute to continuous improvement initiatives within the Quality Assurance function.

Requirements

• A Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 4 years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical manufacturing industry.
• In-depth knowledge of GMP regulations (e.g., ICH Q7, SAHPRA guidelines) and quality management systems.
• Experience with batch record review, deviation management, CAPA, and change control processes.
• Familiarity with internal and external auditing processes.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to clearly document findings and recommendations.
• Proficiency in using electronic quality management systems (eQMS) and standard office software.
• Ability to work independently, manage time effectively, and meet deadlines in a remote work environment.
• Experience in pharmaceutical quality control is a plus.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including an annual bonus.
• Health insurance and a retirement savings plan are provided.
• Significant opportunities for professional development, including training on new regulations and quality systems, are available.
• This role offers the flexibility and autonomy of a fully remote position, eliminating commute time and enhancing work-life balance.
• Access to industry-leading quality systems and resources.
• Join a reputable pharmaceutical company committed to patient safety and product excellence.
• Contribute to the development and manufacturing of life-saving medications.
• This is an excellent career opportunity for a QA professional seeking a remote role in a high-impact sector.