Executive - Product Steward

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
- Position Purpose:

- Responsible for Technology Steward, Product Steward, Ongoing Process Verification, Process & Product related investigation and Post Approval Changes activities at site.
- Your key responsibilities:

- Your responsibilities include, but are not limited to:
- GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. Ensure compliance with Pharmacopoeia/Group Requirements / local and International authorities. Completion of all trainings assigned to role. Ensure integrity of data, good Documentation practices at workplace.
- Product Stewardship:
1. 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.
- 2. Build and maintain a product specific Quality Risk Analysis (QRAs).
- 3. Supervise all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- 4. 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).
- 5. Preparation of OPV documents. Ensure data and trending are visible and communicated at shop floor level. Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
- 6. Assess impact of technical changes, assess their technical feasibility and resolve scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed. Lead/support hold time study activity of assigned product(s).- Technology Stewardship:
7. Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
- 8. Participate in the definition and selection of pharmaceutical equipment, through providing feedback to User Requirements. Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
- 9. Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge to the rest of the organization.
- 10. Be a recognized scientific guide internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents. Maintain their work in inspection readiness level. Support creation of SOPs for Process Unit.- Validation - for the product(s) assigned:
11. Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).
- 12. Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
- 13. To perform periodic audit trail and reviews of the validated excel sheets used in OPV. 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. Review / update QRA prior to validation for technical changes.
- 14. Approve validation protocol and report related to technical changes. Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples.
- 15. Support Validation Lead and Experts to assess need and plan validations, assess revalidation need. For launch assigned, ensure all results related to validation are available including those related to Quality Modules and GOPs.- Product Remediation/ Development for assigned product (s):
16. Initiate and implement development projects, remediation activities.
- 17. Ensure that technical batches generate sufficient knowledge on product & process (CMA, CQA and CPP).- Post approval changes:
18. Preparation, review and approval of document as QRM, QRA, Scale up protocol/BMR/Report, MFR, BMR, BPR, Project approval sheet, Planning phase assessment, ATP, PACPR, PVP, PVR, justifications and Miscellaneous document as per requirement.
- 19. Execution/Monitoring of feasibility/scale up batches on manufacturing sites and monitoring of process validation batches. Trouble shooting of problems faced during manufacturing of post approval batches.
- 20. Attending the meeting and communication with all partners for completion of PAC projects. Initiation, co-ordination, Evaluation, owner approval of change request in Trackwise. Initiation, Investigation and Closure of Quality event, CAPA and OOS in Trackwise. Initiation / Preparation of MRS, Sample request and other GMP document as per relevant SOPs.
- 21. Preparation of New SFG/F