Quality Assurance Specialist with 7+ Years Experience
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Summary: Detail-oriented Biomedical Compliance Specialist with over 7 years of experience in the pharmaceutical industry. Proven track record in ensuring compliance with regulatory standards and guidelines, including FDA and EMA regulations. Skilled in developing and implementing quality management systems, conducting audits, and training staff on compliance procedures. Adept at analyzing complex regulatory documents and collaborating with cross-functional teams to facilitate successful audits and inspections. Strong communication and interpersonal skills, enabling effective collaboration with regulatory bodies and internal stakeholders. Passionate about maintaining high standards of quality and safety in biomedical products, with a commitment to continuous improvement and professional development.
Quality Assurance Specialist · PharmaTech Inc.
- Conducted internal audits to assess compliance with regulatory standards.
- Developed and implemented corrective action plans for non-compliance issues.
- Collaborated with R&D teams to ensure product compliance from development to market.
- Trained staff on quality assurance protocols and compliance regulations.
- Reviewed and approved batch records and deviation reports.
- Participated in regulatory inspections, leading to zero findings in the last three audits.
Key achievements