Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the product(s). Provides second line technical/scientific process support
1. Develop and maintain process and product knowledge form product development stage thought tech transfer and commercial lifecycle (e.g. from raw materials to primary packaging) for products within the PU at Suffern.
2. Single point of the contact to other global product stewards - Liaise with Global Product Steward at global level (other Novartis site that procures the same product) and partner with local site functions such as QA, QC, Engineering, Regulatory, PU and other MS&T process leads with focus on improving process capability and ensuring constant state of validation and continuous control.
3. Continue Process Verification (CPV) and data trending analysis
a. Participate in designing and setting up the CPV program within the site
b. Perform data analysis and data trending analysis on CPV parameters, CPP, IPC data and other critical parameters to help track process performance on a regular bases.
c. Utilize data trending and statistical analysis to help increase process knowledge, flag issues within the process, identify trends deviation and increase process robustness.
d. Work with process SME and QO to initiate appropriate CAPA to ensure successful remediation.
e. Ensure continuous communication of data trending analysis with MS&T, QO and PU and ensure data and trending is visible and communicated at shopfloor level
f. Assist in initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis).
4. Support tech transfer activities (focus on Transfer out) - Provide the necessary data and technical expertise for product transfer to other sites. Ensure appropriate documentations and the know how are transferred to the receiving site.
5. Support investigations and improvement projects (quality, efficiency) by utilize data analysis, involving cross-functional teams to help define the necessary actions to ensure robust process improvement. Additionally, actively participate and represent the product(s) information and updates in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products were planned, prioritized and monitored. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical.
BS/MS in Pharmacy, Chemistry, Chemical / Pharma Engineering and extended technical knowledge in area of own expertise English 5 to 10 years experiences in process support, e.g. process Expert role on the shop floor of a pharmaceutical manufacturing and/or QA/QC. Good Statistical background, and sound experience of data handling and data trending is a must
Novartis - 2 years ago