Website Ref: TPM04449
A QA Operations Specialist is required for a biopharmaceutical company in North Dublin.
- 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 firstname.lastname@example.org.