Quality Assurance Specialist

Acino International AG; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Dubai seeks a motivated individual to join their Quality Assurance team. Responsibilities include document management, ensuring compliance with GMP standards, and participating in audits. Applicants should have relevant experience in the pharmaceutical industry and strong communication skills. This role offers an opportunity to contribute to a dynamic organization focused on growth.

Qualifications

• Relevant experience in the regulated pharmaceutical industry.
• Experience with health authority inspections and third-party audits.
• Understanding of pharmaceutical manufacturing and laboratory work.

Responsibilities

• Manage document issuance, storage, and destruction.
• Ensure compliance with current GMP requirements.
• Prepare and train on standard operating procedures.

Skills

Microsoft Excel

Quality Assurance

Quality Control

Drug Regulatory Affairs

Decision-making skills

Technical writing

Problem solving

Data analysis

Excellent communication skills in English

Job description

Overview

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world. We are constantly expanding our market position with a future-oriented international business strategy. Therefore, we are looking for a dedicated and motivated person to strengthen our Quality Assurance team in Dubai, UAE Site- Acino Pharmaceuticals FZ LLC.

Responsibilities

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

Qualifications & Skills

• 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 communications 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
• Able to work in shifts
• Good communication skills.
• Ability to work as part of a team.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Please apply via our HR system here.