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Senior Specialist, Site Inspections and Compliance
2 months ago
The Senior Specialist for Site Inspections and Compliance is responsible for ensuring the highest level of quality assurance and regulatory compliance within the organization. This role involves conducting audits and reviews to verify compliance with global GMP regulations and corporate requirements.
Key Responsibilities- Quality Assurance and Compliance: Provide support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements.
- Risk Management: Identify and assess risks, and facilitate appropriate mitigations to ensure compliance and continuous improvement.
- Regulatory Inspections: Participate and support Regulatory inspections at the site, including providing responses to regulatory authorities in a timely manner.
- Audit Readiness: Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness.
- Global Collaboration: Work with global colleagues to support the harmonization, maintenance, and application of global audit strategy, processes, and SOPs to improve consistency across the manufacturing sites.
- Regulatory Knowledge: Maintain and share knowledge of Regulations and Guidelines by staying up to date with industry and regulatory trends to ensure compliance and continuous improvement.
- Quality Management: Participate in local Quality Management Review and KPI preparation.
- Education: Bachelor's degree in science discipline, Advanced degree highly regarded.
- Experience: Minimum of 3 years in quality or manufacturing experience in regulated industry, in the biotech or pharmaceutical industries.
- Auditing Experience: Experience as an auditor, internal/external.
- Industry Knowledge: Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations.
- Regulatory Knowledge: Knowledge of global cGMP regulations and ISO standards.
- Communication Skills: Be an effective communicator, and able to prepare written and oral presentations.
- Analytical Skills: Demonstrate the ability to understand data sets and drive to data-based decisions.
- Problem-Solving Skills: Possess excellent analytical and problem-solving skills and use these skills to make sound decisions.
- Organizational Skills: Be well-organized and able to successfully manage deadlines.
- Travel Requirements: Own car and license is required for travel between sites.
