MSD Data Reviewer-Pharm Ops 

Ireland 

294292752

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Data Reviewer is responsible for ensuring all testing activities comply with cGMP.
• Review batches for assigned processes in accordance with regulatory and compendia requirements and to support Internal and Customer Services targets.
• Support Laboratory release of Raw Materials/Excipients/Components and Drug products and by the review of test packages.
• Review all documentation issues with analysts and improve RFT throughout the laboratory.
• Compile and complete all required laboratory metrics.
• Deputise for the Laboratory Co-Ordinator in event of absence and attend Tier meetings as required. Review of data generated by outsourced laboratory for release of Raw Materials/Excipients/Components.
• Review of training to ensure that Analysts can execute the testing function in accordance with company requirements.
• Identify and implement improvements for laboratory systems and develop/update procedures/SOPs as required.
• Participate in and review Laboratory investigations. Follow-up on corrective actions.
• When required assume the role of auditee for the group for internal and external Audits.
• Ensure that corrective actions as a result of audits or deviations are completed and that responses are filed as appropriate.
• Ensure sufficient supplies of standards/comparisons, disposables, reagents and any special requirements.
• Be an active member of the group. Provide support and leadership to the group in team building, release, safety, compliance and improvement objectives.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum education qualifications for this role are Life Sciences degree, or equivalent.
• Procedures policies and guidelines relevant to responsibilities
• Laboratory testing and documentation
• Data integrity requirements including ALCOA and electronic review of data.
• GMP experience.
• Change Control and Deviation system operations and product quality impact.
• Current regulatory environment and regulations/requirements

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.