Assistant Quality Assurance Manager
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Key skills for this role
About the Role
A confidential company is seeking an experienced Assistant Quality Assurance Manager for a full-time, on-site role in Dubai. The role involves supporting the Quality Department in ensuring compliance with pharmaceutical distribution regulations, maintaining the QMS, and leading audits.
Key Skills for This Role
Responsibilities
- Support in maintaining and enhancing the Quality Management System
- Ensure compliance with GDP requirements, regulatory guidelines, ISO standards, and company quality procedures
- Lead and support quality improvement initiatives
- Manage preparation, review, issuance, revision, distribution, and archiving of controlled quality documents
- Plan, conduct, and lead internal audits
- Coordinate and support external audits
- Investigate deviations, non conformities, quality incidents, and customer complaints
- Develop, implement, and monitor Corrective and Preventive Actions (CAPA)
- Ensure GSDP compliance throughout warehousing and distribution activities
- Support qualification, evaluation, requalification, and performance monitoring of suppliers
- Develop and deliver GDP and quality related training programs
Requirements
- Bachelor's Degree in Pharmacy
- Minimum 8 years of progressive experience in Quality Assurance, Quality Management, Compliance or Quality Operations within the pharmaceutical industry
- Proven experience in GDP compliant environments
- Strong experience in managing audits, CAPA systems, deviation investigations, change control, risk management, and document control
Full Job Posting
Job Overview
- We are seeking an experienced and highly motivated Quality Assistant Manager to support the Quality Department in ensuring full compliance with pharmaceutical distribution regulations.
- The role will be responsible for maintaining and continuously improving the Quality Management System (QMS), ensuring adherence to Good Distribution Practices (GDP), applicable ISO standards, local regulatory requirements, and company quality policies.
Key Responsibilities Quality Management System (QMS)
- Support in maintaining and enhancing the Quality Management System.
- Ensure compliance with applicable GDP requirements, regulatory guidelines, ISO standards, customer requirements, and company quality procedures.
- Lead and support quality improvement initiatives across all operational departments.
- Monitor QMS effectiveness through KPIs and quality metrics and propose improvement actions.
Documentation & Compliance
- Manage the preparation, review, issuance, revision, distribution, and archiving of controlled quality documents.
- Ensure all SOPs, policies, work instructions, forms, logs, and quality records are maintained and updated.
- Ensure compliance with document retention requirements and regulatory expectations.
- Prepare quality reports and management review inputs.
Audits & Inspections
- Plan, conduct, and lead the internal audits covering warehouses, transportation activities, suppliers, and service providers.
- Coordinate and support external audits conducted by regulatory authorities, principals, certification bodies, and customers.
- Track audit observations and ensure timely implementation and closure of corrective actions.
- Assist in maintaining audit readiness at all times.
Deviations, CAPA & Risk Management
- Investigate deviations, non conformities, quality incidents, and customer complaints.
- Establish root cause analyses using recognized quality tools and methodologies.
- Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
- Conduct risk assessments and support risk mitigation activities.
- Verify effectiveness of implemented CAPAs.
Warehouse & Distribution Quality Oversight
- Ensure GSDP compliance throughout warehousing and distribution activities.
- Monitor storage conditions and ensure compliance with approved temperature ranges.
- Review temperature mapping studies, qualification reports, and environmental monitoring records.
- Ensure proper implementation and monitoring of cold chain requirements.
- Oversee transportation qualification activities and temperature controlled shipments.
- Support the management of product recalls, product returns, rejected products, and destruction activities.
Supplier & Service Provider Management
- Support qualification, evaluation, requalification, and performance monitoring of suppliers, contractors, and service providers.
- Conduct supplier audits when required.
- Ensure quality agreements are established and maintained with relevant partners.
- Monitor supplier performance and implement improvement plans when necessary.
Training & Quality Culture
- Develop and deliver GDP and quality related training programs.
- Maintain employee training records and verify training effectiveness.
- Promote a strong quality culture across all departments.
- Support employee awareness initiatives related to quality and compliance.
Requirements Education
- Bachelor's Degree in Pharmacy.
- A postgraduate qualification in Quality Management, Regulatory Affairs, or Healthcare Management is considered an advantage.
Experience
- Minimum 8 years of progressive experience in Quality Assurance, Quality Management, Compliance or Quality Operations within the pharmaceutical industry.
- Proven experience in GDP compliant environments.
- Strong experience in managing audits, CAPA systems, deviation investigations, change control, risk management, and document control.
- Experience working with multinational pharmaceutical companies, healthcare distributors, or medical device organizations is highly preferred.
- Experience supporting regulatory inspections by health authorities and internal/external quality audits.
- Strong understanding of pharmaceutical quality systems and their application across manufacturing, supply chain, distribution, and commercialization environments.
- Prior experience working with pharmaceutical distributors, third party logistics providers (3PLs), or GDP regulated supply chain operations is an advantage.
- Demonstrated experience collaborating with regional and global quality teams to ensure compliance with corporate quality standards and regulatory requirements is an advantage.
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