Job Title: Lab Compliance Support Specialist
Job Overview:
Responsible for supporting lab compliance activities to ensure adherence to regulatory and quality standards across all relevant processes.
Key Responsibilities:
Review and approve documents including protocols, reports for method qualification, method validation, method transfer, and investigations.
Handle Quality Issues, Corrective and Preventive Actions (CAPAs), and Change Controls for both clients and contract laboratories.
Collaborate with supported departments to maintain and continuously improve the quality culture, positively influencing Quality KPIs.
Actively participate in business meetings, including CAPA boards, Quality Improvement Programs, and team meetings (e.g., Connect meetings).
Ensure readiness of regulatory documents for publishing and compliance with regulatory requirements.
Support internal and external audits, maintaining adherence to GxP and ICH guidelines.
Qualifications (Minimum Required):
Bachelor’s degree in Pharmacy or related science; advanced degree (Master’s/PhD) preferred. Relevant experience may substitute for educational requirements.
English proficiency: Speaking – ILR level 3+; Writing/Reading – ILR level 4+.
Leadership, problem-solving, and interpersonal skills.
Experience (Minimum Required):
8–10 years in Regulatory Affairs, Quality Assurance, Analytical Science, Formulation Science, Material Management, or overall drug development and manufacturing processes.
Minimum 1 year of project management experience is desirable.
Strong command of written and spoken English.
Technical proficiency with Microsoft Office, document management, and publishing tools.
Good understanding of the pharmaceutical product life cycle, regulatory requirements, GxP, and ICH guidelines.
Scientific or clinical research experience is desirable.
Demonstrated organizational, analytical, and customer-focused skills.
Excellent review skills and concern for quality.
Preferred Qualifications:
Diploma or certification in Regulatory Affairs.
Knowledge of data management systems.
Strong leadership and problem-solving capabilities.
Work Environment:
Office-based environment.
Equal Employment Opportunity:
Learn more about our EEO & Accommodations [here].
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