Barden are delighted to be supporting our rapidly growing Global Pharmaceutical and Healthcare client in their search for a Quality Specialist. The Quality Specialist will provide experience and technical support in QC activities to ensure products are manufactured and distributed in compliance with internal procedures, FDA and applicable regulations.
Additionally, the Quality Specialist will be responsible for the execution and monitoring for repackaged stability activities and for outsourcing analytical and stability services.
Roles & Responsibilities:
- Author, review, and approve documentation.
- Review technical documentation to ensure compliance to quality standards in relation to laboratory and stability activity.
- Analyse and trend data, generate metrics and prepare reports to ensure product issues are escalated and resolved.
- Perform all QC activities to support laboratory testing and stability programmes including but not limited to:
- Review and approve testing data.
- Author and review Writing protocols and /reports to support method development/validation activities.
- Perform HPLC Method development/validation/transfers for new product launches.
- Generate, Track and maintain the stability test programs for re-packaged drug product.
- Oversee and support the method validations/method transfers to outsourced contract Laboratories.
- Facilitate creating and maintaining the schedule for completion of the Annual Stability Program.
- Generate new stability studies, monitor stability pull schedule and track test results.
- Provide technical expertise in the design, implementation, and management of stability studies, including relevant documentation, in line with current regulations.
- Review manufacturers test methods and specifications.
- Support all transfer activities to allow new packager to package products.
- Support contract laboratory activities, such as method transfer, stability testing.
- Liaise with contract laboratories on OOS/OOT investigations.
- Record and track stability data via software system
- Liaise with and support contract laboratories with technical expertise to complete OOS/OOT investigations.
- Conduct technical review and update of associated SOPs and other quality documentation.
- Support contract laboratories with technical expertise.
- Review and approve testing data.
- Writing protocols/reports to support method development/validation activities.
- Perform method validations, or transfers of analytical methods, and subsequent specifications.
- Contribute to a continuous improvement culture and advancement of Quality Control activities.
ABOUT THE PERSON:
Education & Work Experience:
- Bachelor’s degree required ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
- 3+ years pharmaceutical experience in a progressive multinational organization.
- Must have Stability study co-ordination and laboratory experience.
Qualifications/Skills and Knowledge Requirements:
- Solid understanding and knowledge of cGMP and regulatory principles in a finished dose pharmaceutical laboratory environment.
- Good working knowledge of ICH Stability Guidelines and USP 1178 Good Re-packaging practices.
- Excellent communication skills with ability to communicate at all levels within and outside the organization.
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