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vor 3 Monaten
The QC Compliance Specialist is responsible for ensuring that all quality control (QC) activities are conducted in compliance with internal standards, regulatory requirements, and industry best practices. This role involves coordinating and overseeing compliance-related tasks within the QC department, including audits, documentation, training, and continuous improvement initiatives.
Key Responsibilities
- Compliance Monitoring: Monitor QC activities to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal policies.
- Audit Coordination: Coordinate internal and external audits, including preparation, execution, and follow-up on corrective actions.
- Documentation Management: Maintain and oversee QC documentation, ensuring accuracy, completeness, and adherence to regulatory standards.
- Training: Develop and deliver training programs for QC staff to ensure understanding and adherence to compliance requirements.
- Continuous Improvement: Identify opportunities for process improvements within the QC department and lead initiatives to enhance compliance and efficiency.
- Regulatory Updates: Stay updated on changes in regulatory requirements and industry standards, ensuring the QC department remains compliant.
- Deviation Management: Investigate, document, and resolve any deviations or non-conformances in QC processes.
- Collaboration: Work closely with cross-functional teams, including Quality Assurance (QA), Production, and Regulatory Affairs, to ensure overall compliance.
Qualifikationen
- Education: Bachelor's degree in a scientific discipline such as Chemistry, Biology, or a related field.
- Experience: Minimum of 3-5 years of experience in a quality control or quality assurance role within the pharmaceutical or biotechnology industry.
- Knowledge: Strong understanding of GMP, regulatory requirements, and quality management systems.
- Skills:
- Excellent attention to detail and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Proficiency in using quality management software and Microsoft Office Suite.
