QA/RA Specialist - Pharmaceutical GLP/GMP Experience

Synergy is seeking a knowledgeable and meticulous QA/RA Specialist with strong expertise in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) within the pharmaceutical industry.

Requirements

• Develop, review, and maintain quality assurance and regulatory affairs documentation in compliance with GLP and GMP standards.
• Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies.
• Conduct internal audits and inspections to assess compliance with quality systems and regulatory standards.
• Support preparation and management of regulatory submissions and responses to regulatory agencies.
• Collaborate with cross-functional teams to ensure compliance throughout product lifecycle.
• Assist in training laboratory and manufacturing staff on quality system requirements and regulatory standards.
• Investigate and support resolution of deviations, non-conformances, and CAPA activities.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Training & Development