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naukri

Quality Assurance Specialist

Acino Pharma
Dubai, UAE
Senior
9 months ago
Quality ControlQuality Assurance TestingTest StrategyDefect ManagementAgile MethodologiesSQL
Free

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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 ensure good documentation by all the concerned and all the documents are as per current GMP requirements and in-house SOPs.
  • To participate and ensure satisfactory technology transfer, process validation, cleaning validation and hold time studies.
  • To implement CAPA for internal & external audits.
  • Responsible to participate in investigations.
  • To participate in audits and to provide relevant information, when required.
  • To prepare Product quality review.
  • To 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 labelling and arrangement of files, storage, issuance, and retrieval on approved request.
  • Issuance of batch manufacturing and packaging records to production department as per request.
  • Any other responsibilities assigned by department head.
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Qualifications & Skills

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  • 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
  • Good communication skills.
  • Ability to work as part of a team.

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