Job Description

Roles & Responsibilities

Acino is part of Arcera , a diversified life sciences holding company, established by ADQ in Abu Dhabi in 2024 with the purpose to advance innovation in line with the Emirate s 2030 vision for the sector and beyond.

Main Tasks:

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

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• Bachelor s degree in pharmacy
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• Working knowledge of Microsoft excel, word, power point etc.
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• Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
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• Experience with health authority inspections and third-party audits
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• Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset
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  • Decision-making skills.
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  • Excellent communications skills in English (verbal, written, listening, email writing)
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• Technical writing skills
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• Problem solving skills
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• Understanding of manufacturing processes and/or quality systems elements
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  • Data analysis skills are required
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• Able to work in shifts
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• Good communication skills.
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• Ability to work as part of a team.
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