Basel, Switzerland
We are currently looking for a Product Steward candidate that wants to work for a leading global pharmaceutical company. Using scientific innovation and digital technologies to develop breakthrough therapies in areas of great unmet medical need.
As a product Steward you will own the process knowledge of the product(s) assigned throughout the
commercial lifecycle, maintain the oversight on process capability, ensuring process(es) are robust, in continued state of validation and continuously improving.
Tasks:
* Maintain the oversight and knowledge for entire manufacturing process performed on site and
throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
* Create and maintain a product specific Quality Risk Analysis (QRAs).
* Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
* Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
* Lead / support root cause investigation of process failures, initiate and lead product improvement
projects, involving cross-functional teams.
* Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release
parameters in each laboratory (transfer of the product-specific QRA).
* Ensure data and trending are visible and communicated at shop floor level.
* Present product performance and status of product improvement projects in site Manufacturing
Robustness Review Board (MRRB).
* Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
* Contribute to registration strategy and support registration activities.
* Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification
etc.).
* Ensure an appropriate process control strategy based on CQA and where necessary on CPP, CMA is in place, support improving the control strategy where applicable.
* Approve validation protocol and report related to technical changes.
* Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.
* Design and manage optimization projects.
* Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
* Collaborate with OPEX for product / process improvements.
* Own the Training Curriculum for own Job Profile.
* Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
Profile:
* Minimum 8 year experience in process support, e.g. Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC
* Proven process understanding (Pharma, GMP, Regulatory aspects)
* Deep experience of data handling and applied statistics is a must
* BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree
* Preferred MSc. or equivalent experience
* Fluent in English and German desirable
