Cache of job #13854516

Job Title

Validation Team Leader

Employer

ICDS Recruitment

Location

Waterford

Description

Validation Team Leader - County Waterford. Job Purpose: To ensure equipment is maintained in a validated state meeting cGMP requirements. Development, deployment and improvement of validation processes to ensure the maximum levels of performance and compliance are maintained. Key Responsibilities: Health, Safety and the Environment- • Comply at all times with the Health, Safety and Environmental policy and associated procedures. • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do. Quality Compliance- • Ensure all work carried out is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines. • Take ownership for quality compliance in all activities you are responsible for. Engineering- • Ensuring approaches are aligned with current guidelines (ICH/ASTM etc. • Integrating as far as possible Engineering activity and validation activity. • Developing procedures and processes which ensure validation activity is integrated into process design and Engineering execution in new projects and processes. • Develop the site validation schedule and ensure it is scalable in the event of future additions. • Develop validation protocols as required ensuring at all times that acceptance criteria is clear and related to process capability. • Ensure the site change control procedure is integrated into documentation and procedures. • Manage internal and if necessary external outsourced routine requalification of process equipment. • Represent the validation strategy and validation results in audits as required. • Benchmark other industries and organizations to ensure best practice is in use. • Be active in the network, attending conferences/training seminars as needed. Minimum Qualifications & Experience Sought: Qualified to a minimum of Degree level in engineering or related discipline. Minimum 5 years' Validation Engineering experience within a relevant Pharmaceutical environment. 3. Proven track record in the industry in process validation and the development of procedures and processes to support best practice. 4. Ability to understand engineering processes through a logical, data driven, hands on approach. 5. Understanding of current validation best practice. 6. Knowledge of mterile Manufacturing and validation techniques. 7. Experience in Cycle development and validation for sterile manufacturing. 8. Use of FMEA, FMECA and Risk assessment techniques. 9. Familiar with statistical process control methods. 10. Can interact with auditors (internal and external. 11. Proven track record of building relations with equipment vendors. 12. Excellent report writing skills. This job originally appeared on RecruitIreland.com.

Date Added

2257 days ago

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