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Job Description
We are supporting an innovative biotech company pioneering groundbreaking immunotherapy solutions to revolutionize the treatment landscape and transform lives.
As they continue to push their pipeline further including with recent FDA approvals they are now seeking a talented individual to join their Quality team.
Responsibilities:
- Ensuring adherence to company standards, regulatory guidelines, and safety protocols in all operations.
- Conducting root cause analyses, risk assessments, and approvals for quality incidents.
- Managing internal training programs across various business segments.
- Addressing customer complaints from receipt to resolution.
- Handling and approving deviations and corrective/preventive actions.
- Reviewing and approving change controls to ensure regulatory compliance.
- Performing internal audits and participating in external audit initiatives.
- Supporting regulatory inspections and supplier approvals.
- Contributing to continuous improvement efforts within the Quality Management System, including SOP management.
Experience:
- Bachelor's degree in a relevant scientific field with 2-5 years of experience in Pharmaceutical Quality.
- Prior experience in a regulated operational environment, such as peptide pharmaceutical production.
- Proficiency in risk management practices.
- Expertise in multiple quality systems, including document control, deviations, training, auditing, change management, and CAPA.
- Strong verbal and written communication skills.
- Ability to influence and communicate effectively across various organizational levels to promote quality principles.
Get in touch today to find out more!