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. 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.Key Responsibilities:Develop, review, and maintain quality assurance and regulatory affairs documentation in compliance with GLP and GMP standardsEnsure adherence to regulatory requirements from FDA, EMA, and other global regulatory agenciesConduct internal audits and inspections to assess compliance with quality systems and regulatory standardsSupport preparation and management of regulatory submissions and responses to regulatory agenciesCollaborate with cross-functional teams to ensure compliance throughout product lifecycleAssist in training laboratory and manufacturing staff on quality system requirements and regulatory standardsInvestigate and support resolution of deviations, non-conformances, and CAPA activitiesEducation & Experience:Bachelor's degree in life sciences, pharmacy, chemistry, or related fieldMinimum 5 years of experience in pharmaceutical GLP/GMP quality assurance and regulatory affairsStrong knowledge of FDA, EMA regulations, and ICH guidelinesExperience with internal auditing and regulatory inspectionsRequirementsEducation:Bachelor's degree in life sciences, pharmacy, chemistry, or a related disciplineExperience:At least 5 years of hands-on experience in pharmaceutical GLP/GMP QA and regulatory affairsFamiliarity with international regulatory frameworks including FDA, EMA, and ICH guidelinesProven experience conducting internal audits and supporting regulatory inspectionsSkills:Strong attention to detail and organizational skillsExcellent communication and interpersonal abilitiesAbility to work collaboratively with cross-functional teams and manage multiple prioritiesProficiency in quality management systems and documentation practicesBenefitsHealth Care Plan (Medical, Dental & Vision)Paid Time Off (Vacation, Sick & Public Holidays)Training & Development