Quality Assurance Compliance Officer
Modern Pharmaceutical LLC · Doubaï
Descripcion del puesto
About the role
The Quality Assurance Compliance Officer acts as the Quality Responsible Person (RP) ensuring that all operations, infrastructure and storage conditions maintain product quality throughout its lifecycle. The role is based in Muscat, Oman and focuses on compliance with Good Distribution Practice (GDP) regulations and principal contractual requirements.
Key responsibilities
- Establish, implement and maintain a GDP‑compliant Quality Management System (QMS) for storage and distribution of life‑science and medical products.
- Define and enforce controlled processes (SOPs, work instructions, quality checkpoints) across procurement, receipt, storage, inventory, picking, packing, dispatch, transportation and delivery.
- Own GDP quality system elements such as document control, data integrity, change control, internal audits, deviations, CAPA, risk management, validation, calibration, preventive maintenance and temperature monitoring.
- Manage product‑related quality events including complaints, returns, recalls, investigations and disposition decisions.
- Qualify and monitor outsourced activities and service providers, ensuring SLA compliance and ongoing oversight.
- Conduct management reviews, drive continuous improvement based on metrics, audit outcomes and CAPA effectiveness.
- Maintain supply‑chain security controls to prevent contamination, mix‑ups, falsification, tampering or theft.
- Develop and maintain an anti‑bribery and anti‑corruption compliance program aligned with the UK Bribery Act and US FCPA.
Required profile
- Proven experience in quality assurance or compliance within the life‑science, medical‑device or pharmaceutical supply chain.
- Strong knowledge of GDP, QMS implementation and regulatory requirements.
- Familiarity with anti‑bribery legislation such as the UK Bribery Act and US FCPA.
- Ability to lead audits, investigations and continuous‑improvement initiatives.
Required skills
- Good Distribution Practice (GDP) compliance
- Quality Management System (QMS) implementation
- Document and record control
- Data integrity management
- Change control processes
- Internal audit and self‑inspection
- CAPA (Corrective and Preventive Action) handling
- Quality risk management
- Validation/qualification procedures
- Calibration and preventive maintenance
- Temperature monitoring systems
- Supply‑chain security controls
- Knowledge of UK Bribery Act and US FCPA
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Publicado hace 2 días
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Modern Pharmaceutical LLC
Doubaï
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