Job Description
The QA Chemist, – Pharmaceutical Development will provide ongoing supervision of compliant subsystems of the site Quality Management System as it applies to the activities of the Pharmaceutical Development group in the manufacture and testing of APIs for use in pre-clinical and clinical activities.
To follow and assist in the implementation of the GMP standards across the Pharmaceutical Development group. Contribute to Quality processes / initiatives for PD and MSO activities at a local and global level as required particularly in Quality Excellence.
Responsibilities
Implement and maintain the Pharmaceutical Development Quality System aligned with Global CMCE system and Tech Ops Quality Framework.
Ensure all API Development staff are appropriately trained regarding compliance with site and global Quality polices / procedures, cGMP, other relevant guidance and other Quality-technical aspects within the department. Write necessary guideline documents covering Pharmaceutical Development activities where an international guideline is not available or unclear
Oversee change control activities within the Pharmaceutical Development group (arrange meetings, document minutes, assist with technical evaluation / impact analysis / implementation plan and liaise with other Pharm Dev departments for cross-functional changes). Ensure that all changes which may have an impact on quality and compliance within the department are properly evaluated and the corresponding change control is appropriately executed
Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly
Administration of the site document management system as it relates to the API Development department. Review of key study reports, SOPs, and dossier submissions to ensure compliance. Responsible for API Documentation archive
Support internal and external audits (to agreed schedules) and follow-up on any resulting actions. Assist with vendor audits and with external inspections of the Dublin site (IMB, FDA, Global Quality etc.) which may involve the Pharmaceutical Development activities
Support manufacturing activities by performing area and equipment inspections, batch record reviews, and batch release based on testing performed / overseen by the Pharmaceutical Development department
Responsibility for Reference Standard batch record review and batch release
Responsibility for Quality support of equipment and utility management on site as it relates to the Pharmaceutical Development department
Support the Quality oversight for API Contract Manufacturers for development compounds
Participate in site Internal Audit programme
Participate in CMC teams and other cross functional teams as necessary
Update CMC-E Quality team on all aspects of API quality in the context of clinical supply and development
Responsibility for Quality support where appropriate for MSO activities to assist in ensuring that company operations and operating procedures are in compliance with all appropriate cGMP regulations and guidelines, this is to include:
Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required offering a quality perspective on any deviations.
Compilation, Review and Approval of cGMP Documentation
Generation of Annual Product Quality Reviews
Conduct on-site cGMP training, Induction and Refresher, provide input into training topics based on site experience
Minimum:
- BSc. in a scientific, technical, or engineering discipline
- Languages: English
- 5 years relevant experience working in a GMP environment
- To work as part of the QA Team to support the production plan-documentation and batch record review, facility inspection, release and shipping of API.
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