Bachelor's degree in Engineering or Life Sciences required; Master's preferred.
6-9 years in the pharmaceutical or biopharmaceutical sectors with regulated environments.
Strong background in quality validation and regulatory compliance.
Experience leading Corrective and Preventive Action (CAPA) initiatives.
Knowledge of Quality System Regulations (QSR) and GxP standards.
Support validation activities across systems and documentation.
Collaborative skills with cross-functional teams including Quality, Manufacturing, and Regulatory Affairs.
Responsibilities
Develop and oversee quality validation processes for manufacturing.
Lead CAPA investigations and ensure timely resolutions.
Ensure compliance with regulatory standards in all operations.
Champion risk assessments and root cause analyses for quality issues.
Collaborate with teams to improve quality systems and processes.
Assist in validation of equipment, processes, and documentation.
Manage multiple quality-related projects under tight deadlines.
Benefits
Career development opportunities and professional training.
Collaborative work environment with cross-functional teams.
Exposure to high-tech manufacturing processes and innovations.
Contributions to compliance and quality excellence valued.
Participation in continuous improvement initiatives.
Full Job Description
Qualifications & Experience:
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
Strong analytical and problem-solving skills with exceptional attention to detail.
bility to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
Key Competencies:
Quality Validation & Compliance.
CAPA Management.
Regulatory Knowledge (FDA, GMP, GxP, QSR).
Risk Assessment & Root Cause Analysis.
Cross-Functional Collaboration.
Project Management.
Technical Documentation & Reporting.
Continuous Improvement & Quality Excellence.
Skills need:
10+ years of experience in a Quality/Validation role.
Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
Extensive CAPA experience.
Extensive Quality Systems Experience.
Extensive experience in high-speed aseptic filling operations and sterile manufacturing environments.
