Quality Specialist

Confidential Jobs; Dubai; On-site; AED 180,000 - 300,000; Full time

Job summary

Confidential Jobs is seeking a Quality Assurance professional in Dubai to lead compliance with GDP/GSDP and regulatory standards. The role involves developing and enhancing the QMS, managing deviations, CAPA, change controls, and risk assessments, and ensuring inspection readiness.

You will conduct internal audits, participate in external audits, and oversee documentation, supplier qualification, and product release processes to maintain quality across storage, handling, and distribution

Qualifications

• Bachelor's degree in Pharmacy.
• 4-6 years of QA experience in pharmaceutical industry.
• Experience in external audits and regulatory inspections.
• Strong knowledge of GDP/GSDP guidelines, QMS, regulatory requirements and ISO Standards.
• Demonstrated experience managing audits, inspections, and quality system processes.
• High attention to detail with strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work both independently and collaboratively.

Responsibilities

• Ensure full compliance with GDP/GSDP and regulatory requirements.
• Develop, implement, and continuously enhance the QMS.
• Manage quality events, including deviations, CAPA, change controls, and risk assessments.
• Conduct internal audits and actively participate in external audits and regulatory inspections.
• Act as a key contact during regulatory inspections and ensure inspection readiness.
• Maintain and control all quality documentation (SOPs, policies, records).
• Oversee supplier qualification, audits, and ongoing performance monitoring.
• Ensure proper storage, handling, and distribution conditions to maintain product quality and integrity.
• Review and release pharmaceutical products in compliance with procedures and regulatory requirements.
• Provide quality oversight of logistics operations and warehouse activities.
• Manage customer complaints, investigations, and timely follow-up.
• Oversee temperature mapping and validation activities, storage compliance.
• Monitor and report Quality KPIs and implement corrective actions.
• Deliver and support training programs related to quality standards.
• Collaborate with cross-functional teams and promote adherence to regulations and internal policies.
• Drive continuous improvement and reinforce a strong quality culture.

Skills

Quality Assurance

Regulatory knowledge

Auditing

Communication skills

Team collaboration

Education

Bachelor's degree in Pharmacy

Job description

• Ensure full compliance with Good Storage and Distribution Practices (GSDP) and all applicable regulatory requirements.
• Develop, implement, and continuously enhance the QMS.
• Manage quality events, including deviations, CAPA, change controls, and risk assessments.
• Conduct internal audits and actively participate in external audits and regulatory inspections.
• Act as a key point of contact during regulatory inspections, ensuring continuous inspection readiness.
• Maintain and control all quality documentation, including SOPs, policies, and records.
• Oversee supplier qualification, audits, and ongoing performance monitoring.
• Ensure proper storage, handling, and distribution conditions to maintain product quality and integrity.
• Review and release pharmaceutical products in compliance with approved procedures and regulatory requirements.
• Provide quality oversight of logistics operations and warehouse activities, ensuring compliance with GSDP and ISO standards.
• Manage customer complaints, perform investigations, and ensure timely resolution and follow-up.
• Oversee temperature mapping, validation activities, and compliance with storage requirements.
• Monitor and track Quality KPIs, ensuring timely reporting, analysis, and implementation of corrective actions to drive continuous improvement.
• Deliver and support training programs related to quality standards.
• Collaborate with cross-functional teams to ensure adherence to health authority regulations and internal policies.
• Drive continuous improvement initiatives and promote a strong quality culture across the organization.

Candidate Qualifications:

• Bachelor's degree in Pharmacy.
• 4-6 years of experience in Quality Assurance within the pharmaceutical industry.
• Proven hands-on experience in external audits and regulatory inspections.
• Strong knowledge of GDP/GSDP guidelines, QMS, regulatory requirements and ISO Standards.
• Demonstrated experience managing audits, inspections, and quality system processes.
• High attention to detail with strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work both independently and collaboratively in a team environment.