Job Description
A Validation Manager is required by Careerwise recruitment to work with a Co. Clare based pharmaceutical industry client.
Role of this position
1. Generation / Update of the site Master validation plan.
2. This role will be the key participant during site audits and inspections and must be able to clearly understand and explain all site Validation activities to regulators.
3. Interface with other departments such as Engineering, QC, System Users. System Owners, process, Automation / CSV, Warehouse, QA, QA Validation and Manufacturing to ensure that validation project plans are understood and in keeping with site objectives.
4. Generate, review and approve validation, qualification, plans, protocols and reports or assign designee.
5. Understanding of cGMP, good engineering practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
6. Interface with external consultants, suppliers and contractors to ensure successful utility and equipment validations are executed per agreed deliverables and managed within approved PO budgets.
7. Write or assist in writing / reviewing of Validation Policies, Validation SOPS / Templates for site.
8. Coordinate, track and report all Validation and qualification activities across projects and routine operations.
JOB REQUIREMENTS
9. BSc/MSc or BEng/MEng in Engineering or related discipline.
10. 7 - 10 years minimum in validation, quality systems, operations, engineering or any combination thereof.
11. Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
12. Experience with managing teams in a GMP manufacturing environment.
13. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
14. Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.