GMP Experience

synergy•Dallas, TX

About The Position

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. The specialist will be responsible for supporting the implementation, maintenance, and continuous improvement of quality and regulatory compliance systems to ensure adherence to FDA, EMA, and other regulatory requirements. This role involves reviewing procedures, ensuring documentation compliance, conducting internal audits, and assisting with regulatory submissions and inspections.

Requirements

Bachelor’s degree in life sciences, pharmacy, chemistry, or related field.
Minimum 5 years of experience in pharmaceutical GLP/GMP quality assurance and regulatory affairs.
Strong knowledge of FDA, EMA regulations, and ICH guidelines.
Experience with internal auditing and regulatory inspections.
Familiarity with international regulatory frameworks including FDA, EMA, and ICH guidelines.
Proven experience conducting internal audits and supporting regulatory inspections.
Strong attention to detail and organizational skills.
Excellent communication and interpersonal abilities.
Ability to work collaboratively with cross-functional teams and manage multiple priorities.
Proficiency in quality management systems and documentation practices.

Responsibilities

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.