Validation Engineer

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.

The Opportunity:

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 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 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.

QUALIFICATIONS & COMPETENCIES:

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.

WORK ENVIRONMENT: (eg. Office, Production)

Office