Sr. Compliance And Risk Specialist - Pharma
Royal Herbs
Employer Active
Posted 12 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Key Responsibilities
Compliance Management
- Ensure compliance with all relevant pharmaceutical and herbal manufacturing regulations, including EDA, GMP, ISO, and other local/international standards.
- Review and update compliance policies, SOPs, and documentation to align with evolving regulations.
- Conduct compliance audits and internal inspections across departments (Production, QC, QA, Procurement, Warehousing, Farms).
- Prepare and follow up on audit findings, CAPAs, and compliance improvement plans.
- Monitor adherence to Data Integrity, Training, and Documentation requirements.
- Develop, update, and maintain the Enterprise Risk Register covering operational, quality, environmental, and regulatory risks.
- Conduct Risk Assessments (process-based, EDA, training, supply chain, etc.) to identify and mitigate compliance gaps.
- Track and report risk KPIs and ensure mitigation actions are effectively implemented and verified.
- Support departments in implementing preventive controls and monitor their effectiveness.
- Prepare compliance and risk dashboards and reports for management review.
- Coordinate Management Review Meetings (MRMs) to present compliance performance, risks, and improvement recommendations.
- Ensure documentation integrity and traceability for all compliance-related activities.
- Develop and deliver compliance awareness and risk-based training programs for staff.
- Support cross-functional teams in understanding and applying compliance best practices.
- Act as a key point of contact for regulatory bodies (e.g., EDA, MoH, ISO auditors) and ensure readiness for inspections.
- Liaise with consultants, certification bodies, and external auditors during audits and compliance reviews.
Desired Candidate Profile
- Bachelor s degree in Pharmacy (Master s or certifications in Risk/Compliance is a plus).
- Minimum 3 years of experience in pharmaceutical, herbal, or food manufacturing sectors.
- Strong knowledge of GMP, GACP, ISO 9001, ISO 22000, and EDA regulatory requirements.
- Experience in risk assessment, CAPA management, and audit preparation.
- Excellent analytical, documentation, and reporting skills.
Company Industry
- Agriculture
- Dairy
- Poultry
- Livestock
Department / Functional Area
- Finance
- Treasury
Keywords
- Sr. Compliance And Risk Specialist - Pharma
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