QA Operations Specialist

QA Operations Specialist – Pharmaceuticals – 11 Month Contract – Dublin

Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a QA Operations Specialist to join their risk management team in Dublin on their newest large-scale facility project.

This is a fantastic opportunity to be part of fast-paced project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills. This is a truly exciting project which, when complete, will contribute to the manufacturing of a life changing treatment.

We are searching for a QA Operations Specialist to specialist in Risk Assessment, and Risk Management. This is initially an 11 month contract, but with an excellent opportunity for extensions and long term assignments.

QA Operations Specialist Responsibilities:

• Support quality aspects of drug substance manufacturing to ensure compliance with company policies, procedures and regulatory expectations. 
• Provide Quality oversight to Upstream maufacturing 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.

Experience required for this QA Operations position:

• This role requires a minimum of 3 years experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmceutical industry. 
• A self-starter and results-focussed, the successful candidate will have strong contemporary 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.

Does this QA Specialist position sound like a good next career step for you? Get in touch with us today to start your application.

The candidate must have the rights to work in the location stated in the job advert.

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