- Your primary focus will be providing support and guidance on routine quality - related issues.
- Provide Quality Assurance review and disposition of commercial lots of drug substance, product and finished goods.
- Must start, monitor, as well as complete change controls related to Quality topics
- Prepare and review applicable sections of regulatory submissions
- Distribute work to Quality Assurance staff to assure timely review of batch documentation,
- Lead investigation teams and ensure proper close out and follow - up.
- Lead off-site visits and teleconferences for discussion and review of supplier performance to established schedules and cGMP compliance.
- Create and/or review deviations and investigations to assess cGMP compliance of lots.
- 3-5 years of direct GMP experience in Pharma, Biologics or Solid Dosing Capacity.
- BA/BS (or Masters) in any Life Science discipline preferred, and/or 8+ years experience in GxP Drug Manufacturing industry.
- Microsoft office skills.
- Proven project management skills/ multitasking skills in previous roles - planning, projects etc.
- Will need to both understand and apply good working knowledge of quality and GMP principles
- Positive work attitude, must support teamwork and continuous improvement.
- Must have the ability to handle multiple tasks concurrently and in a timely fashion.
- Wrist and hand motion are required (e.g. writing, typing)
Sthree US is acting as an Employment Business in relation to this vacancy.