Quality Assurance Specialist

منذ 4 أسابيع

Sharjah city, Sharjah, الإمارات العربية المتحدة Acino Pharma دوام كامل

مجانًا عبر البريد الإلكتروني أو Google

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Main TasksResponsible 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.

QualificationsBachelor'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.

Quality Assurance Specialist

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وظائف مشابهة في Sharjah city

عروض مماثلة

الأمريكتين

أوروبا

آسيا / أوقيانوسيا

أفريقيا

Quality Assurance Specialist

احفظ هذه الوظيفة وحافظ على تنظيم بحثك

وظائف مشابهة في Sharjah city

عروض مماثلة