5-9 years of experience in highly regulated environments like pharmaceuticals or biopharmaceuticals.
Bachelor's degree in Engineering, Life Sciences, or similar; Master's degree preferred.
Strong background in quality validation and regulatory compliance.
Experience in aseptic filling operations and sterile manufacturing is a plus.
Demonstrated CAPA investigation and management experience.
Exceptional analytical and problem-solving abilities with attention to detail.
Proficient in managing multiple projects under strict timelines.
Responsibilities
Support validation activities including equipment, processes, facilities, and documentation.
Lead and manage CAPA investigations to ensure compliance and continual improvement.
Collaborate with cross-functional teams to enhance quality and operational success.
Conduct risk assessments and root cause analyses for quality issues.
Develop and maintain technical documentation and reporting for validation activities.
Implement best practices in quality systems and compliance training.
Oversee adherence to regulatory standards like FDA, GMP, and QSR.
Benefits
Opportunity to work in a fast-paced, regulated environment.
Collaboration with diverse cross-functional teams.
Access to advanced training and development initiatives.
Contribution to impactful projects within the life sciences industry.
Full Job Description
Requirements:
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.
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.
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.
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.
