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Details

Senior QA Operations Manager


Reference:AIFL-782125 Location: Limerick
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Specialist

Senior QA Operations Manager
Our client, a growing biopharmaceutical organisation are currently hiring for a
Senior QA Operations Manager to join their team. As Senior QA Ops Manager you will be responsible for all aspects of assigned QA Team, provides leadership and support to direct reports. You will provide QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

Responsibilities
• Responsible for all aspects of QA Team including review and approval of the following types of documents, Master records, executed records, failure investigations, Change Controls, SOPs, validation protocols and summary reports & incursions
• Approve various documents relating to area function, including those listed above.
• Organize QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management
• Perform compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
• Review customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality
• Provide advice and direction to other company departments on quality issues
• Participates in regulatory and customer audit

Requirements
• BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred)
• experience in a pharmaceutical/biologics manufacturing environment desired
• Minimum 8 years experience in biopharma/ pharmaceutical industry
• 3+ of those years to include leadership and/or supervisory experience

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252