A Senior QA Validation Manager is required by Careerwise Recruitment to work for our Limerick based client.
Role of this position
- Developing validation approaches with CMC teams such that external validation efforts align with commercial expectations and are timely with regards to planned regulatory filing dates.
- Reviews and approves validation documentation associated with filling, visual inspection, labelling, assembly, product sterilization, packaging and technology transfer. Documentation may include Validation plans, development reports, process control strategies, protocols, reports and risk assessments.
- Reviews Regulatory filing sections related to completed external validation activities.
- Interfaces routinely with internal teams including CMC, Drug Product, External Manufacturing, QC, QA and Regulatory.
- BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field of Biotech Process sciences, Validation, Manufacturing or related field.
- Experience in cGMP operations and managing of personnel is required.
- Travel estimated at 30-50%.
Please call Michael O'Connor today for further information on 091-452410 or email firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)