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Quality Assurance Specialist

Acino·Salary not specified

Primary stack

Quality AssuranceComplianceProblem Solving

Nice to have's

Microsoft ExcelMicrosoft WordMicrosoft PowerPointCommunication SkillsTeamwork

Job description

About the Position

Acino, a pharmaceutical company headquartered in Zurich and part of Arcera, is seeking a Quality Assurance Specialist for its operations in Dubai, United Arab Emirates. This role is integral to ensuring on-floor GMP compliance during manufacturing and packaging, and supporting batch release activities.

Responsibilities

  • Ensure on-floor GMP compliance during manufacturing and packaging.
  • Support batch release activities through in-process oversight, batch record review, deviation escalation, and verification of compliance.
  • Responsible for document management including issuance, storage, retention, and destruction of documents and records.
  • Ensure good documentation by all concerned personnel and 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 respective batch records.
  • Monitor manufacturing/packing activities on a routine basis.
  • Ensure compliance in Warehouse, Manufacturing, and Packing.
  • Review batch records, associated data, logbooks, and track monthly batch release activities.
  • Review master documents.
  • Ensure 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 & external audits.
  • Participate in investigations.
  • Participate in audits and provide relevant information when required.
  • Prepare product quality reviews.
  • Participate in qualification activities.
  • Ensure safe work practices and usage of recommended PPE during activities.
  • Ensure compliance to EHS policy and its requirements.
  • Manage document room including labeling, arrangement of files, storage, issuance, and retrieval on approved request.
  • Issue batch manufacturing and packaging records to the production department as per request.
  • Any other responsibilities assigned by the 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) is 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

  • Competitive salary.
  • Opportunity to work in a dynamic and rapidly growing environment.
  • Professional development opportunities.
  • Be part of a company that is challenging the status quo in the pharmaceutical industry.

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.

Acino is an Equal Opportunity Employer.

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.

© Acino. This job description was sourced from the employer's public career page. TheJob is not the employer — we index the posting and route candidates to the source. All content rights and hiring decisions belong to the employer.

As a Swiss pharmaceutical company headquartered in Zurich, we develop, manufacture and internationally market well-proven and innovative pharmaceuticals in novel drug delivery forms.

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