QA Officer (Part-Time)

  • Cork
  • Temporary 12 months
  • JO-1905-64513_1561976226

Summary

Responsibilities:

  • Batch record review and release
  • Approve/close deviations and propose CAPAs.
  • Make sure cGMP are applied.
  • To propose ideas for Quality System efficiencies' and effectiveness' improvement.
  • To assure that all implemented procedures are followed, according to company and customer requirements as established in specific Quality or Technical agreement.
  • To manage all quality activities.
  • To promote the importance of high-quality levels and the importance of a continuous improvement culture in all core company activities.
  • Work with operational departments to establish procedures, standards and systems that assure and improve compliance with the cGMPs.
  • Access health authorities, customer and industry requirements and ensure that these are met.
  • Prepare and review quality related documentation i.e SOP Review and approval, protocols etc.
  • Identify training needs and organize training sessions. Provide training.
  • Prepare Product Quality Review and propose applicable action plans
  • Represents client audits and health authorities' inspection.
  • Prepare, conduct and document internal and external audits.
  • Evaluate and approve suppliers
  • Manage client complaints.

Requirements:

  • Sc .in Chemistry, Chemical Engineering, Pharmacy or equivalent degree in a scientific area
  • cGMP knowledge;
  • English fluency (written and oral)
  • Ability to collaborate and communicate effectively across functional groups
  • Experience in Operational areas (RD or Manufacturing);Experience in Quality Assurance area is preferable.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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