Quality Assurance Specialist
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Key skills for this role
About the Role
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.
Key Skills for This Role
Responsibilities
- Responsible for document management including issuance, storage, retention, and destruction of documents and records
- Ensure good documentation practices and compliance with GMP and SOPs
- Preparation of 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
- Monitor manufacturing/packing activities on routine basis
- Review batch records including associated data, logbooks, and track monthly batch release activities
- Participate in technology transfer, process validation, cleaning validation, and hold time studies
- Implement CAPA for internal and external audits
- Participate in investigations and audits
- Prepare Product quality review
- Participate in qualification activities
Requirements
- Bachelor's degree in Pharmacy
- Relevant experience in regulated pharmaceutical industry, specifically QA, QC, or Drug Regulatory Affairs
- Experience with health authority inspections and third party audits
- Understanding of pharmaceutical manufacturing and laboratory work
- Excellent communication skills in English
- Technical writing skills
- Problem solving skills
- Data analysis skills
- Able to work in shifts
Full Job Posting
Overview
- Acino is part of Arcera, a diversified life sciences holding company, established by ADQ in Abu Dhabi in 2024.
Main Tasks
- Responsible for document management such as issuance, storage, retention and destruction of documents and records as per defined procedure.
- To ensure good documentation by all concerned personnel and all the documents are as per current GMP requirements and in house SOPs.
- Preparation of standard operating procedure and provide training on SOPs.
- Responsible for maintaining audit documents such as regulatory and customer audit report and response.
- To ensure that batch production operations are carried out in accordance with cGMP and procedure mentioned in respective batch record.
- Monitoring of manufacturing/packing activities on routine basis.
- Ensure compliance in Warehouse, Manufacturing and Packing.
- To review the batch records including associated data, logbooks etc and to track monthly batch release activities.
- To review master documents.
- Ensure that cGMP requirements are been followed and monitored in the critical process areas.
- To participate and ensure satisfactory technology transfer, process validation, cleaning validation and hold time studies.
- To implement CAPA for internal & external audits.
Qualifications & Skills
- Bachelor s degree in pharmacy
- Working knowledge of Microsoft excel, word, power point etc.
- Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/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) a strong asset
- Decision making skills.
- Excellent communications skills in English (verbal, written, listening, email writing)
- Technical writing skills
- Problem solving skills
- Understanding of manufacturing processes and/or quality systems elements
- Data analysis skills are required
- Able to work in shifts
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