Indivior is looking to improve operations, manufacture batches, reduce lead times, and increase capacity by ensuring that all relevant process raw materials, intermediates, and final products are manufactured, packaged, tested, and released in full compliance with cGMP and regulatory requirements.
Requirements
- Broad Knowledge of sterile manufacturing.
- Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
- Collects, understands, interprets and trends data on the quality system performance.
- Strong computer skills including Microsoft platform and Visio.
- Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA.
Responsibilities
- Provide direct INDV QA assistance for the resolution of deviations, escalations, and material disposition.
- Provide final INDV QA review of formulation, manufacturing, bulk packaging, and inspection records to ensure GMP completeness, accuracy and legibility.
- Provide final INDV QA review of secondary packaging records and activities
- Provide surge support for INDV QA Release for Supply Activities for final commercial batch disposition, as required
- Provide INDV QA review of artwork and component changes
- Provide INDV QA oversight of supplier, component and material changes impacting bulk manufacturing and secondary packaging.
- Provide direct support for all related continuous improvement activities as applicable.
Other
- Minimum 10% Travel
- Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
- Proven track record, minimum five (5) years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
- Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks.
- Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
