Regulatory Documentation Specialist

6 days ago


Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

About PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

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We are a leading global medical services company dedicated to delivering high-quality healthcare solutions. Our team is passionate about making a difference in people's lives, and we're looking for talented individuals like you to join us

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Job Title: Regulatory Documentation Specialist

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Salary: $80,000 - $110,000 per annum (dependent on experience)

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Job Description:

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We are seeking an experienced Regulatory Documentation Specialist to join our team in Singapore. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with cGMP regulations and maintaining accurate documentation records.

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Your primary duties will include:

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  • Supporting the generation of qualification protocols, SOPs, and production batch records;">
  • Coordinating internal review and approval of documentation;">
  • Proactively progressing documents to achieve schedule adherence and site policies & compliance with cGMP's;">
  • Initiating Production Change Control, deviation, and handling of related CAPA activities;">
  • Updating and formatting documentation, including SOPs, forms, logbooks, and label templates;">
  • Preparing label templates and printing labels as required for finished product;">
  • Writing/reviewing manufacturing documentation (SOPs, Manufacturing Records & Logbooks) to ensure accuracy and compliance with regulatory requirements;">
  • Tracking and trending relevant technical and business process metrics to ensure operations are performing effectively and efficiently;">
  • Arranging quotation and purchasing requisitioning all required production consumables;">
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Requirements:

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To be successful in this role, you will need:

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  • A minimum Diploma qualification in life science, engineering or related field;">
  • A minimum of 5 years' experience working in a regulated manufacturing environment;">
  • Experience in a cGMP facility, in a documentation role is desirable;">
  • Excellent computer skills in MS Office (WORD, EXCEL, PowerPoint);">
  • Good communication and interpersonal skills;">
  • CAPA, Microsoft Excel, Archiving, Trend, Labels, Consumables, MS Office, PowerPoint, Change Control, Business Process, Regulatory Requirements, Manufacturing knowledge;">
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Benefits:

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We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you're a motivated and detail-oriented individual who is passionate about regulatory compliance, we encourage you to apply for this exciting opportunity

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Apply Now:



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