Quality Assurance Specialist

About the Position

Quality Assurance Specialist

Acino, a part of Arcera, is a pharmaceutical company with a focus on selected markets in the Middle East, Africa, and Latin America, as well as Ukraine and Eurasian countries. We are seeking a Quality Assurance Specialist to join our team in Dubai, United Arab Emirates. This role involves ensuring compliance with GMP and cGMP standards, participating in audits and investigations, and managing document processes.

Responsibilities

• Responsible for document management such as issuance, storage, retention, and destruction of documents and records as per defined procedures.
• Ensure good documentation by all concerned personnel and that all documents are as per current GMP requirements and in-house SOPs.
• Prepare standard operating procedures and provide training on SOPs.
• Maintain audit documents such as regulatory and customer audit reports and responses.
• Ensure that batch production operations are carried out in accordance with cGMP and the procedures mentioned in respective batch records.
• Monitor manufacturing/packing activities on a routine basis.
• Ensure compliance in Warehouse, Manufacturing, and Packing.
• Review batch records including associated data, logbooks, etc., and track monthly batch release activities.
• Review master documents.
• Ensure that cGMP requirements are followed and monitored in critical process areas.
• Participate and ensure satisfactory technology transfer, process validation, cleaning validation, and hold time studies.
• Implement CAPA for internal & external audits.
• Participate in investigations.
• Participate in audits and provide relevant information when required.
• Prepare product quality reviews.
• Participate in qualification activities.
• Ensure safe work practices and usage of recommended PPE during activities.
• Ensure compliance with EHS policy and its requirements.
• Manage the document room including labeling and arrangement of files, storage, issuance, and retrieval on approved request.
• Issue batch manufacturing and packaging records to the production department as per request.
• Any other responsibilities assigned by the department head.

Requirements

• Bachelor’s degree in pharmacy.
• Working knowledge of Microsoft Excel, Word, PowerPoint, etc.
• Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs.
• Experience with health authority inspections and third-party audits.
• Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) is a strong asset.
• Decision-making skills.
• Excellent communication skills in English (verbal, written, listening, email writing).
• Technical writing skills.
• Problem-solving skills.
• Understanding of manufacturing processes and/or quality systems elements.
• Data analysis skills are required.
• Ability to work in shifts.
• Good communication skills.
• Ability to work as part of a team.

We Offer

• Opportunity to join a dynamic organization.
• Active participation in shaping the future of the company.

About the Company

Established in 1836, Acino, part of Arcera, is a pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, and Latin America, as well as Ukraine and Eurasian countries. With over 3,000 people across 90 countries, we deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets. We also leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.

Acino is part of Arcera, a diversified life sciences holding company, established by ADQ in Abu Dhabi in 2024 with the purpose to advance innovation in line with the Emirate’s 2030 vision for the sector and beyond.

If this sounds exciting, we would love to hear more about you! Please apply via our HR system here.