Quality Assurance Specialist

Acino Pharma; Dubai; On-site; AED 220,345 - 293,793; Full time

Job summary

Acino Pharma, located in Dubai, is looking for a qualified professional for a Quality Assurance role. Responsibilities include managing document compliance, ensuring adherence to GMP standards, and conducting audits. Candidates should hold a Bachelor’s in Pharmacy and possess relevant experience in Quality Assurance or Drug Regulatory Affairs.

The ideal applicant will have excellent communication skills, strong decision-making abilities, and familiarity with various analytical techniques, as well as the ability to work in shifts.

Qualifications

• Relevant experience in Quality Assurance, Quality Control, or Drug Regulatory Affairs in the pharmaceutical industry.
• Experience with health authority inspections and third-party audits.
• Understanding of pharmaceutical manufacturing and laboratory work.

Responsibilities

• Responsible for document management as per defined procedures.
• Ensure compliance with GMP and in-house SOPs.
• Prepare SOPs and provide training.
• Monitor compliance in Manufacturing and Packing activities.
• Review and track batch release activities.

Skills

Excellent communication skills in English

Problem-solving skills

Strong decision-making skills

Data analysis skills

Technical writing skills

Ability to work as part of a team

Understanding of manufacturing processes

Ability to work in shifts

Education

Bachelor’s degree in Pharmacy

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Main Tasks

• Responsible for document management: issuance, storage, retention, and destruction of documents and records as per defined procedures.
• Ensure good documentation by all personnel; keep documents in compliance with 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 batch production operations are carried out in accordance with cGMP and the procedures mentioned in respective batch records.
• Monitor manufacturing and packing activities on a routine basis; ensure compliance in Warehouse, Manufacturing, and Packing.
• Review batch records, 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 and external audits.
• Participate in investigations and audits; provide relevant information when required.
• Prepare product quality reviews and participate in qualification activities.
• Ensure safe work practices and use of recommended PPE during activities; comply with EHS policy and its requirements.
• Manage the document room, including labeling, arranging files, storage, issuance, and retrieval upon approved requests.
• Issue batch manufacturing and packaging records to the production department as requested.
• Perform any other responsibilities assigned by the department head.

Qualifications

• Bachelor’s degree in Pharmacy.
• Working knowledge of Microsoft Excel, Word, PowerPoint, etc.
• Relevant experience in the regulated pharmaceutical industry, specifically in Quality Assurance, Quality Control, 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.
• Strong decision‑making skills.
• Excellent communication skills in English (verbal, written, listening, email writing).
• Technical writing skills.
• Problem‑solving skills.
• Understanding of manufacturing processes and quality systems elements.
• Data analysis skills.
• Ability to work in shifts.
• Good communication skills.
• Ability to work as part of a team.