18525-Quality Operations Quality Specialist-Dublin Contractor

Purpose:

We are seeking a self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations, and current industry trends. This role will be a 12/4 shift role. 4 consecutive 4 12 hr shifts followed by 4 days off rolling.

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 a 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.

Requirements:

• Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
• This role requires a minimum of 3 years of experience in, Quality Assurance, Technical Operations, or Engineering within the Biopharma / Pharmaceutical industry.
• Experience working in a regulated environment with exposure to the Regulations & guidance – 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.