Job Description

ADCAN Pharma is a premier UAE-based pharmaceutical manufacturer located in Abu Dhabi, contributing to the UAE’s Vision 2030 and the “Make it in the Emirates” initiative. As the first and only Oncology and Hormones manufacturer in the UAE, our products meet international GMP standards and serve key markets in the MENA region. With state-of-the-art, cGMP-compliant facilities in the Industrial City of Abu Dhabi (ICAD), we focus on quality, innovation, and operational excellence. Our diverse portfolio includes medications across Oncology, Hormones, and General therapeutic areas. Committed to improving lives, we are a trusted partner in healthcare innovation and medicines security.

Role Description

Responsible for executing and timely completing assigned Quality Assurance activities to ensure compliance with GMP and regulatory requirements, while maintaining high-quality standards across manufacturing operations. The role includes oversight of document control systems, QMS activities, and cross-functional coordination to support efficient operations. Additionally, the position involves review of analytical data and audit trails of QC computerized systems to ensure data integrity, accuracy, and compliance with ALCOA+ principles and regulatory expectations.

Collaborate with cross-functional teams and execute quality assurance activities for the smooth running of manufacturing operations to meet business objectives.

Implement strategies to optimize the quality & efficiency of processes in manufacturing.

Collect raw data to prepare trend analyses to identify opportunities for improvement and drive business performance.

Close monitoring of GMP activities executed at ADCAN Pharma facility to ensure alignment with established regulatory requirements.

Maintain transparency with internal & external partners.

Play a key role in performing quality-related activities requested by stakeholders.

Ensure timely completion of customer complaint investigations, proposing appropriate CAPAs, and implementing the proposed CAPAs.

Provide training to team members, enforce teamwork, and enhance the accuracy and consistency of quality through refresher training.

Arrange day to day meetings to enhance the problem-solving skills of QA personnel involved in quality processes.

Continuous shop floor monitoring to maintain quality throughout the manufacturing process and ensure compliance with regulatory requirements.

Serve as a subject matter expert during audits (related to QA activities on the shop floor), offering guidance and support to QA team members on quality-related matters.

GMP Requirements / Others:

Prepare Standard Operating Procedures (SOPs) and all Quality Management System (QMS) related documents, SMF, Quality Manual, Risk Assessment etc.,

Review and verification of analytical data (HPLC, GC, UV, Dissolution, etc.), including raw data, chromatograms, and analytical data sheets, ensuring compliance with GMP and data integrity principles.

Perform audit trail review of QC computerized systems (e.g., Empower, Lab Solutions) to detect any data manipulation and ensure adherence to ALCOA+ and regulatory data integrity requirements.

Review the Master Formula Records, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), analytical data sheets (ADS), Specification, Standard testing methods, and Certificate of Analysis of finished product.

Assessment & investigation of all the QMS elements like Change controls, Deviation reports, OOS, OOT, CAPA etc., & Annual Product Quality Reviews (APQRs) & Supplier’s Qualification documents.

Execute document control activities for effective implementation of Quality Management System as per cGMP guidelines.

Arrange and verify Technology Transfer documents, Stability compilation data (dossier documents) for CMO qualifications.

Preparation of investigation reports for quality-related complaints, returned goods, and recalls.

Support in vendor/supplier qualifications, audits (internal and external), and self-inspections.

Provide technical support for all the cross functional departments.

Preparation and Review of Protocols like Process validation, cleaning validation, risk assessments and miscellaneous activities.

Responsible for executing equipment, instrument, facility, and area qualifications, as well as manufacturing process-related activities from dispensing to product dispatch, including sampling and in-process testing.

Perform any additional GMP tasks assigned by the management or reporting manager

Qualifications

Bachelor’s degree in pharmacy.

Minimum 08 years’ experience in quality assurance department in the pharmaceutical industry.

Skills:

1. Well knowledge of regulations and GMP requirements.

2. Problem-solving and decision-making skills

3. Communication skills.

4. Leadership talents.

5. Familiarity with LIMS systems (e.g., Empower & Lab Solutions)

6. Strong knowledge of analytical techniques (HPLC, GC, UV, Dissolution, etc.)

7. Experience in analytical data review and interpretation.

8. Hands-on experience in audit trail review and data integrity compliance.

Certifications:

1. Certified Pharmacist

Other:

1. Good skills in MS Office

2. SAP knowledge

3. Good team working & communication skills in English.

4. Time management

5. Flexibility under pressure and in response to changing needs.