Quality Specialist

Role Summary:
We are seeking a meticulous and detail-oriented Quality Specialist to join our growing team. The Quality Specialist will be responsible for ensuring that our biopharmaceutical products and processes comply with all relevant regulatory requirements and internal quality standards. This role plays a crucial part in maintaining the integrity and safety of our products throughout their lifecycle.

Key Responsibilities:
- Assist in the development, implementation, and maintenance of the Quality Management System (QMS).
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch records, deviation reports, and change controls.
- Participate in CAPA (Corrective and Preventive Actions) investigations and implementation.
- Monitor and ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant guidelines.
- Prepare and maintain quality-related documentation, including SOPs and training materials.
- Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) to address quality issues.
- Support validation activities for equipment, processes, and analytical methods.
- Stay updated on evolving regulatory requirements and industry best practices.