Job ID: JOB-13052
An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments.
- Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning.
- Manage the validation requirements of third party suppliers and CMO’s.
- Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation).
- To maintain and take responsibility for the cleaning validation strategy
- To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU.
- Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
- Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams.
- Establishing, implementing and directing validation and revalidation activities.
- Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
- Reviewing and managing Change Control Forms for Validation implications.
- Reviewing and managing Non-Conformance’s for Validation Implications.
- Updating existing quality documentation related to validation activities.
- Identifying training requirements in support of validation.
- Ensuring completion of validation protocols.
- Carry out Internal Audits as required.
- Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
- Maintaining validation documentation system.
- Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
- Assisting in the preparation and hosting of associated regulatory and customer audits.
- Minimum Bachelor of Science or Engineering.
- 4-5 years’ experience in a pharmaceutical environment.
- Good computer skills with Word, Excel and any other statistical programs.
- Knowledge of Process and Cleaning Validation.
- Ability to conduct internal audits.
- Ability to perform in external audits
For further information on this role in Galway please contact Aisling Kidney on 0872197421 or email@example.com
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