Senior Pharmaceutical Quality Assurance Specialist (Remote)

Placements24; Lorenziberg; A distancia; EUR 90.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Health, dental, vision insurance

Retirement savings plan

Paid time off

Remote work from home

Descripción de la vacante

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Specialist to join a remote-first team dedicated to ensuring product and process compliance with cGMP and regulatory standards. You will develop, implement, and maintain a robust Quality Management System (QMS) and lead audits across global operations.

The role requires 7+ years in QA/QC, strong regulatory knowledge, auditing, CAPA and change control expertise, and excellent remote collaboration and documentation abilities.

Formación

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology or related life sciences.
• Minimum 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Strong knowledge of cGMP, ICH guidelines and regulatory standards (FDA, EMA, SAHPRA).
• Proven experience in auditing, deviation management, CAPA and change control processes.
• Excellent written and verbal communication for remote collaboration and documentation.

Responsabilidades

• Develop, implement, and maintain the Quality Management System (QMS) in line with cGMP and regulations.
• Conduct internal and external audits of suppliers, contract manufacturers, and processes.
• Manage deviations, OOS results, and CAPA processes.
• Review and approve batch records, validation protocols, and quality docs.
• Participate in regulatory inspections and respond to agency queries.
• Provide training on QA principles and GMP compliance.

Conocimientos

Quality Assurance

Auditing

CAPA

Change Control

Regulatory Compliance

Analytical Thinking

Remote Collaboration

Educación

Bachelor's degree in Pharmacy, Chemistry, or Microbiology

Herramientas

Quality Management Software

Descripción del empleo

About the Role

Our client, a leading pharmaceutical organization renowned for its commitment to excellence, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their fully remote team. This critical position will ensure that all pharmaceutical products and processes comply with stringent quality standards and regulatory requirements. You will be instrumental in developing, implementing, and maintaining robust quality management systems, conducting audits, and driving continuous improvement initiatives. This is a remote-first role that demands a proactive approach, exceptional attention to detail, and the ability to collaborate effectively with global teams through digital platforms. We are looking for a self-motivated professional with a deep understanding of GMP and a proven ability to uphold the highest standards of pharmaceutical quality from anywhere. Your contributions will be vital in safeguarding product integrity and patient safety.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP and other relevant regulations.
• Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
• Manage deviations, out-of-specification (OOS) results, and CAPA processes.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Participate in regulatory inspections and respond to regulatory agency queries.
• Provide training to personnel on quality assurance principles and GMP compliance.
• Monitor key quality metrics and performance indicators, reporting on trends and areas for improvement.
• Collaborate with various departments (e.g., R&D, Manufacturing, Quality Control) to ensure quality is integrated throughout the product lifecycle.
• Stay current with evolving regulatory requirements and industry best practices.
• Support the qualification and validation of equipment and processes.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related life science discipline.
• Minimum of 7 years of experience in pharmaceutical Quality Assurance or Quality Control.
• Comprehensive knowledge of cGMP, ICH guidelines, and other relevant regulatory standards (e.g., FDA, EMA, SAHPRA).
• Proven experience in auditing, deviation management, CAPA, and change control processes.
• Strong understanding of pharmaceutical manufacturing operations and product lifecycle.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, essential for remote collaboration and documentation.
• Demonstrated ability to work independently, manage multiple tasks, and meet deadlines in a remote environment.
• Proficiency in quality management software and tools.

Benefits

• Our client offers a competitive salary, comprehensive health, dental, and vision insurance, a robust retirement savings plan, and generous paid time off.
• This fully remote position offers the flexibility to work from home and provides opportunities for continuous learning and professional growth.
• We are committed to supporting our remote employees with the resources they need to succeed and foster a collaborative virtual work culture.
• This role offers a significant opportunity to impact product quality and patient safety within a mission-driven organization.