- Support Third party manufacturers on batch review documentation, deviations and incident reports.
- Prepare and assess change control documentation, while review the annual product quality reports.
- Involved in the QMS development and continuous improvement, supporting senior executives on batch reviews and any deviations.
- Providing Quality Oversight of all products being released into US Market. The products are manufactured by third party Injectable manufacturing sites based in Bangalore.
- This role supports affiliate injectable sites, an experience in third party manufacturing oversight and/or sterile manufacture is ideally required to help with analytical investigations.
- Be involved in compliance and complaint investigations for the QA operations, meeting face to face with third party manufacturers and discussing batche reviews and deviations.
- Minimum of 5+ Years experience in the quality management and compliance area in Pharmaceutical or Medical Device
- Understanding the role of Quality in the Pharmaceutical business
- Strong Planner
- Good time-keeping
- Working closely with senior leadership
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent