Our client is a leading CDMO pharmaceutical organization seeking an experienced Quality professional to step into a Senior Specialist role. This is a global entity with a strong presence in the European market, and the role offers a fantastic opportunity to contribute to their growth, while scaling and evolving your own professional path.
The Senior Quality Specialist– Qualification & Validation is responsible for ensuring compliance with regulatory requirements, industry standards, and company policies related to qualification, validation, and quality assurance in a pharmaceutical manufacturing environment. This role involves leading validation activities for equipment, facilities, utilities, cleaning processes, and computerized systems to maintain the highest standards of product quality and regulatory compliance. Additionally, the role requires expertise in managing a Quality Management System (QMS), writing Standard Operating Procedures (SOPs) and work instructions, and conducting root cause analysis and risk assessments to improve compliance and operational efficiency.
Responsibilities will span the following disciplines:
* Quality Assurance & Compliance
* Validation & Qualification Management
* Leadership & Cross-Functional Collaboration
* Documentation & Data Integrity
* Root Cause & Risk Analysis
Qualifications and experience required:
* Education: Bachelor's or Master’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related field.
* Experience: Minimum of 4-8 years of experience in pharmaceutical or biotech manufacturing with a strong focus on validation, qualification, and quality management.
* Expertise in:
* Equipment, facility, and utility qualification (HVAC, Fridges and Freezers and temperature controlled storage areas etc.)..
* Computerized system validation (CSV) and data integrity compliance.
* GMP compliance, risk-based validation approaches, and regulatory audits.
* Managing QMS, writing and maintaining SOPs and work instructions.
* Performing root cause analysis, risk management, and CAPA investigations.
* Technical Skills: Proficiency in FDA, EMA, ICH Q7-Q10, ISO 9001, and EU GMP Annex 11 and 15 validation requirements.
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