Tech Stack
Job Description, Responsibilities & Requirements
About the Position
Quality Assurance Specialist
Dubai, United Arab Emirates
Established in 1836, Acino, part of Arcera, is a pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, and Latin America, as well as Ukraine and Eurasian countries. With over 3,000 people across 90 countries, we deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets. We also leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing.
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.
Responsibilities
- Ensure on-floor GMP compliance during manufacturing and packaging and support batch release activities through in-process oversight, batch record review, deviation escalation, and verification of compliance prior to batch disposition.
- Responsible for document management such as issuance, storage, retention, and destruction of documents and records as per defined procedure.
- Ensure good documentation by all concerned personnel and all the documents are as per current GMP requirements and in-house SOPs.
- Prepare standard operating procedures and provide training on SOPs.
- Responsible for maintaining audit documents such as regulatory and customer audit reports and responses.
- Ensure that batch production operations are carried out in accordance with cGMP and procedure mentioned in respective batch records.
- Monitor manufacturing/packing activities on a routine basis.
- Ensure compliance in Warehouse, Manufacturing, and Packing.
- Review batch records including associated data, logbooks, etc., and track monthly batch release activities.
- Review master documents.
- Ensure that cGMP requirements are followed and monitored in the critical process areas.
- Participate and ensure satisfactory technology transfer, process validation, cleaning validation, and hold time studies.
- Implement CAPA for internal & external audits.
- Responsible to participate in investigations.
- Participate in audits and provide relevant information when required.
- Prepare Product quality review.
- Participate in qualification activities.
- Ensure safe work practices and usage of recommended PPE during activity.
- Ensure compliance to EHS policy and its requirements.
- Responsible for management of document room including labeling and arrangement of files, storage, issuance, and retrieval on approved request.
- Issue batch manufacturing and packaging records to production department as per request.
- Any other responsibilities assigned by department head.
Requirements
- Bachelor’s degree in pharmacy
- Working knowledge of Microsoft Excel, Word, PowerPoint, 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 communication 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
- Good communication skills
- Ability to work as part of a team
We Offer
Join Acino, a dynamic and rapidly growing environment where your contributions can make a real difference.
Acino is an Equal Opportunity Employer.
About the Company
At Acino, we push the boundaries to deliver high-quality pharmaceutical products that improve patients’ lives. Driven by our collective purpose to provide access to medicines to those in need, our strength lies in our unique expertise and presence in emerging and high-growth markets. We are proud to be challenging the status quo in the pharmaceutical industry, always looking ahead to the future with an open mind.
How To Apply
Please apply via our HR system. Only direct applications will be considered.
Please Note
Please note that our company name as well as names of members of the management committee are occasionally misused by third parties for scamming, particularly in the context of fake job offers.
We would never ask for down payments in relation to job applications. Should you have any doubt as to the authenticity of a job proposal, please contact us.