QA Operations Specialist – Upstream (Shift)

Website Ref: TPM04449

Summary:
A QA Operations Specialist is required for a biopharmaceutical company in North Dublin.

Responsibilities:

  • Support quality aspects of drug substance manufacturing to ensure compliance with company policies, procedures, and regulatory expectations.
  • Provide Quality oversight to upstream manufacturing activities on the production floor as part of facility start up and routine manufacturing.
  • Review and approval of site operations Standard Operating Procedures (SOPs) and Work Instructions (WI).
  • Support electronic batch record review and review of related batch documentation to ensure timely release and disposition of drug substance batches.
  • Review will encompass review of production and equipment logbooks and audit trails.
  • Support sustaining activities such as Deviation and Change Management.
  • Serve as a quality resource for assessing Quality Risk Assessments.
  • Use of Quality Risk Management and Operational Excellence to promote continuous improvement.
  • Provide quality oversight for engineering changes impacting manufacturing equipment.

Qualifications & Experience:

  • Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline.
  • This role requires a minimum of 5 years’ experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
  • Knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
    Experience in batch record review and review of batch related documentation.
  • Technical experience in aseptic processing or manufacturing operations.
  • Experience with new product introductions and/or process qualification/technology transfer.
  • This role will be a 12/4 shift role: 4 consecutives 12 hours shifts followed by 4 days off.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.