A key role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Officer will be responsible for reviewing and issuing validation protocols and reports. This role is also responsible for the co-ordination and execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments within the Chanelle Group.
Key Responsibilities:
* Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning
* Manage the validation requirements of Chanelle and 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 at Chanelle
* 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 team
* 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-Conformances for Validation Implications
* Updating existing quality documentation related to validation activities
* Identifying training requirements in support of validation
* Ensuring completion of validation protocols
* Conduct Internal Audits as required
* Responsible for the execution of Risk Assessments or Investigation reports relative to the role
* 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
Qualifications & Competencies:
* Good verbal and written communication skills and the ability to work independently in an analytical environment
* Good computer skills with Word, Excel, and any other statistical programs
* Knowledge of Process and Cleaning Validation
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