Overview:
An important role in the QA department, reporting directly to the Head of Quality, 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
KEY RESPONSIBILITIES:
• Contribute on the preparation and review of the Validation Master Plan – Process and
Cleaning
• Manage the validation requirements 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
• 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-Conformances 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
COMPETENCIES:
- B.Sc. / M.Sc. in Scientific Discipline
- HPRA / USFDA Experience
- Minimum 2 years relative experience in a similar position
- Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
- Proactive, motivated, analytical and strategic thinker.
- Good verbal and written communication skills and the ability to work independently in analytical; 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
QUALIFICATIONS:
Minimum Bachelor of Science or Engineering
