Job Description
Are you ready to elevate your career at the forefront of medical innovation? Aetheria Life Sciences is seeking a meticulous and driven Senior QA Specialist to ensure our groundbreaking therapeutic pipelines meet the highest global regulatory standards.
You will play a pivotal role in our quality management system, working in a fast-paced, mission-driven environment where patient safety is our North Star.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in alignment with cGMP regulations.
- Conduct thorough internal and external audits to ensure compliance with FDA and EMA standards.
- Manage the CAPA (Corrective and Preventive Action) program, ensuring timely resolution of deviations.
- Review and approve batch records, standard operating procedures, and validation protocols.
- Provide expert guidance to cross-functional teams regarding quality compliance during clinical trial phases.
- Lead continuous improvement initiatives to streamline quality processes and operational efficiency.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5-7 years of direct experience in pharmaceutical quality assurance.
- In-depth knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Strong problem-solving skills with a high attention to detail in technical documentation.
- Proven ability to effectively communicate regulatory requirements to non-compliance stakeholders.
- Industry certification (e.g., ASQ CQA) is considered a strong advantage.