QC Specialist

4 weeks ago

Cork, Cork, Ireland Scientificjobs Full time

QC Specialist – Method Transfer

Main Responsibilities:

  • Planning and execution of method transfers, ensuring seamless transfer of analytical methods.
  • Leading analytical investigations and problem-solving activities to resolve quality control issues.
  • Preparing and writing analytical documents linked to the method transfer process.
  • Validating and qualifying analytical equipment to ensure accuracy and reliability.
  • Training personnel for execution, review, and completion of documentation.
  • Reviewing and approving validation documentation for team members upon request.

Compliance:

  • Maintaining system documentation, including SOPs, protocols, and Validation lifecycle/CSV documentation.
  • Owning quality systems actions (IR's, CAPA, CC) to ensure timely closure and performance trending.
  • Participating in internal and external audits and actively following up on audit items.
  • Identifying productivity and compliance opportunities and driving them to completion.

Qualifications and Experience:

  • Minimum 2 years of experience in the pharmaceutical or medical device industry.
  • Degree (or equivalent) in Chemistry, Microbiology, or a related Science/Engineering subject.
  • Experience in method transfers, with a focus on quality control and assurance.
  • Validated qualification of analytical equipment, ensuring data integrity and accuracy.
  • Familiarity with QC systems and processes, particularly LIMS, MODA & Veeva.
  • Proven experience in data compilation, review, and report generation.
  • Data Integrity requirements for QC, ensuring regulatory compliance.
  • Project Management skills, including leadership, oversight, and contributory roles.

Skills Required:

  • High attention to detail, with a focus on accuracy and precision.
  • Self-motivated, goal-driven individual with a strong sense of accountability.
  • Technical problem-solving skills, with the ability to analyze complex data sets.
  • Strong organizational skills, with the ability to prioritize tasks and manage multiple projects.
  • Ability to perform, challenge, and positively influence in an interactive team environment.

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