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