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Senior Specialist, Site Inspections and Compliance
2 months ago
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Healthcare Professionals Group. As a Senior Specialist, Site Inspections and Compliance, you will be responsible for ensuring the highest standards of quality and compliance across our global operations.
Key Responsibilities- Quality Assurance and Compliance: Conduct regular site inspections and audits to ensure compliance with global GMP regulations and corporate requirements.
- Risk Management: Identify and assess risks, and implement mitigations to ensure compliance and continuous improvement.
- Regulatory Inspections: Participate in and support regulatory inspections at our sites, providing timely responses to regulatory authorities.
- Audit Readiness: Maintain and improve processes, procedures, and SOPs for auditing and inspections to ensure audit readiness.
- Global Collaboration: Work with global colleagues to harmonize, maintain, and apply global audit strategy, processes, and SOPs to improve consistency across our manufacturing sites.
- Regulatory Knowledge: Maintain and share knowledge of regulations and guidelines by staying up-to-date with industry and regulatory trends.
- Quality Management: Participate in local Quality Management Review and KPI preparation.
- Education: Bachelor's degree in a science discipline, with an advanced degree highly regarded.
- Experience: Minimum of 3 years in quality or manufacturing experience in a regulated industry, preferably in the biotech or pharmaceutical industries.
- Skills: Experience as an auditor, internal or external; knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations; knowledge of global cGMP regulations and ISO standards.
- Personal Qualities: Effective communication and presentation skills; ability to understand data sets and drive data-based decisions; excellent analytical and problem-solving skills; ability to work well under pressure and manage deadlines.
Healthcare Professionals Group is a leading recruitment agency specializing in healthcare and life sciences recruitment. We pride ourselves on providing a supportive and stable working environment, with opportunities for career growth and development.
