
Pharmaceutical Technical Expert
6 days ago
As a Technical Product Specialist, you will be responsible for ensuring the quality and integrity of our pharmaceutical products throughout their entire lifecycle. This includes overseeing all aspects of product development, from initial concept to commercialization, as well as maintaining relationships with internal stakeholders and external partners.
Key Responsibilities:- Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization site.
- Provide input to formal stage gates during development and up to first OPV/APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirements.
- Support development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.).
- Responsible for the validation oversight and for maintaining the product in constant state of validation.
- Challenge defined control strategy based on CQA and where necessary on CPP, CMA prior to validation and for defined improvement projects.
What You'll Bring:
- Minimum 8 years of experience in pharmaceutical (chemical) manufacturing.
- Experience in a global/matrix environment in the pharmaceutical industry.
- Comprehensive know-how in pharmaceutical (chemical) technology.
- Project Management experience.
- Drug Development experience.
- Sound experience of data handling and applied statistics.
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