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Senior Specialist, Quality Assurance and Compliance
2 months ago
As a Senior Specialist for Site Inspections and Compliance, you will play a critical role in ensuring the quality and compliance of our biotechnology products. Your responsibilities will include conducting audits and reviews of data and documentation to verify compliance with global GMP regulations and corporate requirements. You will also identify and assess risks, facilitating appropriate mitigations to ensure compliance and continuous improvement.
Key Responsibilities
- Support the preparation and execution of Self-Inspections to verify compliance with global GMP regulations and corporate requirements
- Identify and assess risks, and facilitate appropriate mitigations to ensure compliance and continuous improvement
- Participate and support Regulatory inspections at the site, including providing responses to regulatory authorities in a timely manner
- Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness
- Work with global colleagues to support the harmonization, maintenance, and application of global audit strategy, processes, and SOPs to improve consistency across manufacturing sites
- Maintain and share knowledge of Regulations and Guidelines by staying up to date with industry and regulatory trends to ensure compliance and continuous improvement
- Participate in local Quality Management Review and KPI preparation
Requirements
- Bachelor's degree in a science discipline, Advanced degree highly regarded
- Minimum of 3 years in quality or manufacturing experience in a regulated industry, in the biotech or pharmaceutical industries
- Experience as an auditor, internal/external
- Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations
- Knowledge of global cGMP regulations and ISO standards
- Effective communication and presentation skills
- Ability to understand data sets and drive data-based decisions
- Excellent analytical and problem-solving skills
- Well-organized and able to manage deadlines
- Own car and license required for travel between sites