5-9 years of relevant experience in highly regulated manufacturing environments like pharmaceuticals or biopharmaceuticals.
Strong background in quality validation, regulatory compliance, and Quality System Regulations (QSR).
Proven leadership experience in managing Corrective and Preventive Action (CAPA) activities.
Bachelor's degree in Engineering, Life Sciences, or similar; Master's degree preferred.
Experience in high-speed aseptic filling and sterile manufacturing is advantageous.
Exceptional problem-solving skills and a strong attention to detail.
Responsibilities
Lead validation activities for equipment, processes, facilities, and computerized systems.
Oversee documentation review to ensure compliance with regulations.
Manage and conduct CAPA investigations and implementations.
Collaborate with cross-functional teams to enhance compliance and operational efficiency.
Develop and maintain quality systems that align with industry best practices.
Present complex information effectively to diverse audiences.
Handle multiple projects simultaneously while adhering to strict deadlines.
Benefits
Opportunity to work in a fast-paced, regulated environment.
Chance to collaborate with multi-disciplinary teams in the life sciences industry.
Professional development and growth potential within the organization.
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.
