Operations Expert

Acino International AG; Dubai; On-site; AED 150,000 - 180,000; Full time

Job summary

A pharmaceutical company in Dubai is seeking a Quality Operations Expert to oversee quality assurance activities across manufacturing. The ideal candidate will possess a degree in Pharmaceutical Sciences and have 8-10 years of experience in IPQA. Strong knowledge of cGMP and effective communication skills are essential. This role offers a dynamic work environment where you can influence the company's future.

Qualifications

• 8-10 years of progressive experience in the pharmaceutical industry.
• In-depth knowledge of oral solid dosage form manufacturing processes.
• Strong understanding of cGMP, GDP, and Data Integrity principles.

Responsibilities

• Ensure compliance with cGMP during batch production operations.
• Monitor manufacturing/packing activities through IPQA.
• Review batch documents for regulatory submission.

Skills

In-Process Quality Assurance (IPQA)

Attention to detail

Analytical skills

Collaboration

Education

Master’s or Bachelor’s degree in Pharmaceutical Sciences

Tools

eQMS (TrackWise, IQVIA)

Job description

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 team in Dubai, UAE Site- Acino Pharmaceuticals FZ LLC.

Role Overview

The Quality Operations Expert will be responsible for overseeing in-process quality assurance (IPQA) activities across all stages of manufacturing. This includes ensuring strict adherence to Good Manufacturing Practices (GMP), safeguarding data integrity principles (ALCOA++), and proactively monitoring operations to identify and mitigate quality risks. The role plays a critical part in maintaining consistent product quality, safety, and efficacy while driving a culture of compliance and continuous improvement within the organization.

Main Tasks:

• To ensure that batch production operations are carried out in accordance with cGMPs and applicable regulations
• Monitoring of manufacturing/packing activities through IPQA activities on routine basis.
• Issuance of documents like batch manufacturing and packaging records etc.
• To review batch documents related to regulatory submission [batch records and associated data].
• 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 and timely technology transfer, process validation and cleaning validation studies.
• Initiation, handling and review of non-conformances, deviation, change control, CAPA and Coordinate in absence of QMS coordinator.
• Preparation and review of Investigations related to Product complaints & ensure that appropriate measures are taken to prevent recurrence.
• To participate in audits and to provide relevant information, when required.
• Review of all GMP master documents like IMFPC, MFPC, Batch records.
• To ensure awareness of cGMP requirements are evaluated, updated through periodic training & carry out On the Job Training to the Shop Floor personnel.
• Responsible to ensure the execution of validation activity as per the annual validation and revalidation planner as per Validation Master Plan.
• Preparation and review of protocols and reports of process validation, Hold time and cleaning validation.
• Participate in execution of qualification and requalification activities as per scheduler.
• Preparation of Annual product review.
• Preparation of Standard operating procedure and provide training on SOPs

Qualifications & Skills:

• Master’s or Bachelor’s degree in Pharmaceutical Sciences.
• 8-10 years of progressive experience in In-Process Quality Assurance (IPQA) within the pharmaceutical industry.
• In-depth knowledge of oral solid dosage form (OSD) manufacturing processes and IPQA practices.
• Hands-on experience with electronic Quality Management Systems (eQMS), including modules such as TrackWise and IQVIA.
• Strong understanding of cGMP, GDP and Data Integrity principles aligned with ALCOA++.
• Exceptional attention to detail, with proven analytical, critical-thinking, and problem-solving abilities.
• Exposure of working with USFDA & EU approved facility in a similar role.
• Effective communicator with strong collaboration and teamwork capabilities, fostering cross-functional alignment.
• Flexible and resilient in managing dynamic work environments, shifting priorities, and cross-functional demands.

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.