QA Specialist

  • Cork
  • Permanent
  • JO-1711-62979_1510744416

Summary


Responsibilities

  • Work in an FDA / HPRA approved Drug Product Intermediate (DPI) and Active Pharmaceutical Ingredient (API) manufacturing facility.
  • Ensure compliance to new and established systems, global regulations and guidelines for a wide range of DPIs, APIs and intermediates.
  • Promote a mature quality culture.
  • Issuance, control and review of production batch records.
  • Review/release of all APIs; Pre-QP batch record review for DPIs.
  • Lead and participate in validation activities including issuance of process validation protocols, reports and VMPs.
  • Participate in cross functional teams for the introduction of new products/processes.
  • Preparation/approval of cleaning documentation.
  • Participate in cross functional investigations, advise on corrective actions and assist with their implementation
  • Carryout GMP training.
  • Participate in all aspects of audits by Regulatory Authorities and Customers
  • Conduct internal audits as per agreed schedules
  • Deputise in the absence of other Quality Assurance Specialists when requested
  • To take reasonable care for your health and safety and for others in the workplace

Requirements

  • BSc in a technical or scientific based subject.
  • Minimum of 5+ years in a QA Specialist, Validation or Compliance Role in a Regulated Industry (API/ Drug Product/ Biopharma, Medical device, etc)
  • Competent and knowledgeable of all relevant ICH guidelines, particularly ICHQ7, EU GMP guide and other relevant guidelines
  • Work as part of a team with an emphasis on continual improvement
  • Flexible with excellent communication skills, ability to work on own initiative
  • Knowledgeable in computerised systems validation is an advantage.
  • Eligibility to become a Qualified Person is an advantage

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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