Reporting to the QA Director, The QA Validation Team Lead will:
- Assure cGMP compliance before, during and after validation/qualification activities by assuring that all necessary procedures are implemented and are being followed on the site.
- Approve and/or carry out the Design, Installation, Operational Qualification and Performance Qualification of new or changed process systems, equipment, utilities and facilities. Conduct 21 CFR part 11 assessments.
- To co-ordinate and coach QA, Engineering, Maintenance and Manufacturing areas, promoting a continuous improvement culture compliant with the applicable regulations and approved procedures
Provide cGMP and Technical Guidance on Validation activities on site.
- To plan and establish Qualification/Validation requirements for each project.
- To assure that systems, including automated process control systems, equipment, utilities and facilities are qualified/validated according to their intended use and product requirements in accordance with Procedures and Regulatory Guidelines.
- To promote the importance of high quality standards and the importance of a continuous improvement culture in core company activities.
- To participate in the alignment and harmonization of the Qualification and Validation procedures within all sites.
- To align Qualification and Validation methodologies in Automation, Engineering, Maintenance, and Production Areas to benefit systems compliance.
- To establish the required qualification activities of new or changed systems and/or facilities within the change control process.
- To conduct periodic review of systems.
- Provide guidance on validation activities for APIs and DPIs on site.
- Generate or approve protocols, reports and periodic reviews of systems.
- Approve equipment, maintenance and automation Change Control Requests
- Coordinate and/or carry out the URS/DQ/IQ/OQ tasks, for all new or changed process/utilities systems in close liaison with the Engineering area.
- To participate in the management of Quality Systems key activities related to the job mission, procedures, policies and cGMPs training.
- To prepare/review/approve Quality Systems methodologies related to the area objectives and assuring adequate training on site is provided to all departments in relation to validation/qualification activities.
- To assure and promote compliance on Health, Safety and Environment.
- To establish qualification/validation related procedures and documents.
- To actively participate in customer audits.
- To support all regulatory inspections.
- To pro-actively manage all Deviations, CAPAs, Improvement Plans and Change Control activities related to Qualification and Validation of all Projects, Equipment, Facilities and Utilities.
- BSc Chemistry or equivalent
- Minimum of 4 years' experience in Qualification & Validation work with at least 2 years' experience gained in a commercial API environment;
- Good general knowledge on Quality, cGMPs, ICH and ISO guidelines as well as experience on their application;
- Strong Technical Knowledge of Project Engineering applied to Process equipment, facilities, utilities and HVAC systems
- Formalised Training in Risk Assessment/Analysis techniques
- Excellent communication skills;
- Ability to discuss technical aspects of Qualification and Validation with clients, suppliers and health authorities;
- Proactive approach to all activities - "Can do - Will Do" attitude
- Excellent attention to detail with an analytical and objective approach to review
- Must be able to work on own Initiative with minimal supervision.
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