Quality Control Chemist

  • Contract
  • Cork

Website TPM04886

Our client is a bio pharmaceutical company based in East Cork looking for a QC Chemist role who will be responsible for analytical operations including Analytical Method Transfers, New Product Introductions, process & cleaning optimisations, technical investigations and quality control testing to support our GMP operations.


  • Involvement in Analytical Method Validation/Transfers for Solid Oral Dosage & for Biological Products as appropriate.
  • Execution of process and cleaning validation studies in support of New Product Introductions.
  • Provision of technical support to Operations for investigations and optimisation projects.
  • Deliver new technologies and continuous improvement initiatives to meet business requirements.
  • Support QC investigations/troubleshooting and technical projects within the function.
  • Support the procurement and qualification of new equipment for new product technology transfers.
  • Demonstrates skills in data analysis (ex: UPLC, HPLC, CE,) and ability to critically evaluate data quality.
  • Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
  • Writes and executes protocols and reports.
  • Assists in the training of QC staff.
  • Writes and revises methods, specifications, and SOP’s as needed.
  • May develop methods for performing cleaning validations.
  • Demonstrates and applies an advanced level of understanding of project goals and methods
  • Knowledge of current Good Manufacturing Practices
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills
  • Executes analysis efficiently, consistently, and with high quality and suggests improvements.
  • Acts as a resource for other employees within the department.
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • Interfaces with key cross functional stakeholders locally, CTLs and across our client’s international sites.

Qualifications & Experience:

  • 5+ years of relevant experience with BA or BSc degree in Chemistry.
  • 3+ years of relevant experience with MSc degree in Chemistry.
  • Experience in test methods for Solid Oral Dosage products.
  • Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
  • Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
  • Hands-on experience with equipment qualification and analytical techniques such as UPLC/HPLC, Water content analysis etc.
  • Knowledge of software such as Empower and LIMS.
  • Ability to engage and manage multiple stakeholders to achieve the objective.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.