| || Located in Boucherville, the Canadian division of Sandoz houses one of the most important sterile pharmaceutical manufacturing sites in the country. Our vision: to become the main provider of high quality, affordable medicines and help secure long-term access to healthcare for people around the world. If you are results oriented and recognized for your leadership, expertise, commitment to quality and customers, come join our team!
We are currently looking for a Product Steward:
Reporting to the Transfert technology Product Steward Manager, the Product Steward owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the 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. Stewardship-for the products assigned :
Create and maintain product specific Quality Risk Management (QRMs) and maintain the oversight and knowledge throughout the entire commercial lifecycle.
Execute testing protocol to get process / product knowledge or assess risk
Review / update QRM prior to validation for technical changes
Ensure an appropriate process control strategy based on CQA (Critical Quality attribute) and where necessary on CPP (Critical Process Parameter), CMA (Critical Material Attribute) is in place, supporting improving the control strategy where applicable.
Responsible for ensuring the continues state of validation (process, ongoing verification)
Monitor all critical variable and key variables as appropriate using statistical analysis and conducting regular product specific data trending (OPV: ongoing process verification)
Track and evaluate product performance, trending detect issue, implementation of CAPA
Lead / support root cause investigation of process failure, initiate and lead product improvement projects, involving cross-functional teams
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
Ensure Creation of master Batch Record
Contribute to registration strategy and support registration activities.
2. ALaunch and Transfer- for the products assigned
Act as a SME for technical transfer
Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Design of technical batches for transfer
Provide input into overall project strategy and plans including timelines
Review key documents from transferring site (QRM, Control Strategy, Manufacturing Process Transfer Protocol)
Initiate local change control in system and ensure approval and closure.
Prepared, coordinate and attend the execution of registration batches.
Review and prepared key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate)
Write manufacturing process transfer document (protocol, report)
Ensure site readiness for product launch and alignment with regulatory affairs.
Prepared technical activities for product launch.
Create product Quality Risk Management (QRM) prior launch and process validation
3. Manufacturing Excellence-for the product(s) assigned :
Design and manage optimization projects
Initiated and support investigation and improvement projects
Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability
Collaborate with OPEX for products / process improvements
Assess source change and execute technical batch to support
Responsible for batch size scale-up
Support production and laboratories for product issue
4. Training & Audit support :
Own the training curriculum for its Job Profile and provides the necessary training and support to new associated joining position
Health and safety minute training
Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit
Act as SME during Health Authorities’ Inspections.
5. Project leader or team member for special projects or site improvement (ex. Primary components, API source changes, tubing changes etc) (% of time allocated may differs when the product steward is the project leader, this is adjusted in the individual annual objective)
| || BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree;
Three (3) to five (5) years’ experience in pharmaceutical industry (manufacturing, Development) Transfert Tech;
Good knowledge of pharmaceutical production equipment, manufacturing process science and technologies;
Good knowledge of statistical tools for process performance analysis, Team work;
Good knowledge of GMP;
Good communication skills in French and English;
Attention to detail, good workmanship and good teamwork skills.
At Sandoz Canada, we are committed to equitable access to employment opportunities and workplace diversity.
Only candidates selected for an interview will be contacted.