GMP QA Specialist: Documentation & Audits

Acino International AG; Dubai; On-site; AED 180,000 - 300,000; Full time

Job summary

Acino International AG in Dubai seeks a Quality Assurance Documentation Specialist to manage document control in a GMP environment. You will ensure proper issuance, storage, retention and destruction of records and support cGMP compliance across manufacturing, packaging and warehouse operations.

Responsibilities include preparing SOPs, training, maintaining audit documents, reviewing batch records, supporting technology transfer, validation activities and CAPA processes.

Qualifications

• Bachelor's degree in pharmacy with relevant industry experience preferred.
• Experience with health authority inspections and third-party audits is essential.
• Strong knowledge of GMP and regulatory affairs in pharma.
• Excellent written and verbal English communication.

Responsibilities

• Manage document control including issuance, storage, retention and destruction of documents and records per SOPs.
• Ensure documents comply with current GMP requirements and in-house SOPs.
• Prepare SOPs and provide training on SOPs.
• Maintain audit documents and respond to regulatory/customer audits.
• Review batch production records and monitor monthly batch release activities.
• Ensure cGMP compliance across Warehouse, Manufacturing and Packing.
• Participate in technology transfer, process validation, cleaning validation and hold time studies.
• Implement CAPA and participate in investigations and audits.
• Prepare Product Quality Review and support qualification activities.

Skills

Microsoft Excel

Microsoft Word

PowerPoint

Quality Assurance

Quality Control

Drug Regulatory Affairs

Health authority inspections

Third-party audits

GMP

Data analysis

Technical writing

Teamwork

Communication skills

Education

Bachelor’s degree in pharmacy

Job description

Acino International AG in Dubai seeks a Quality Assurance Documentation Specialist to manage document control in a GMP environment. You will ensure proper issuance, storage, retention and destruction of records and support cGMP compliance across manufacturing, packaging and warehouse operations.

Responsibilities include preparing SOPs, training, maintaining audit documents, reviewing batch records, supporting technology transfer, validation activities and CAPA processes.