Msat Product Expert

**Site Name**: Singapore - Tuas
**Posted Date**: Oct 2 2024

MSAT department is focused on the potential of science to address the unmet needs of patients. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

MSAT Product Stewardship team manages the entire lifecycle of products manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products. Product Steward and Product Expert oversight and ownership of all changes related to product (i.e. process change, raw material change that has potential impact to product & process) with the end to end view from incoming materials to finished product. MSAT Product Stewardship team implements and maintains the control strategy for drug substance production and introduces lifecycle changes (manages eCC for process parameters, process materials etc).

The team drives process lifecycle management for next generation and continuous improvement of biologics drug substance manufacturing. They provide technical oversight of our commercial products and processes with an end to end view and throughout their lifecycle. They monitor process performance and product quality with CPV cycle. Holistic view of how the following inputs from other pillars of MSAT department has a cumulative impact on the process during PQR review such as (1) deviations & CAPAs, new validation/requirements from MSAT Manufacturing Support, (2) new understanding of the process from MSAT Process Science & Manufacturing Technology that leads to update of CPP, TRA & PCS, (3) new equipment, raw material, process parameters from MSAT Technology Transfer that could impact the process performance.

**Continued Process Verification**:

- Participate to the CPV cycle of the designated product.
- Assist the Product Steward to manage CPV / QRB meetings
- Review and analysis process trending identify changing quality trends and issues.
- With the support of Product Steward, suggest corrective actions to solve issue and improve the robustness and consistency of the manufacturing process.
- Responsible of the initiation and maintenance of TRA, PCS, DTP, CQA and QTTP of the designated product.
- Compile, interpret, and organize process and product data for periodic reviews, as well as audits / regulatory support.
- Closely interact with the MSAT Manufacturing Support Engineers and VS to monitor process performance through real-time performance data. Collect, record, and product report metrics.
- Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
- Read and interpret statistical diagrams, drawings, and other schematics. Monitor processes for performance and problem indicators.
- Update and manage the lifecycle of the process History file of the product.
- Aide users in both the Discoverant and PKM systems. Provide training as needed for both systems.
- Assess impact of changes on current validated process status and identify need for revalidation/revaluation activities.
- Provide product expertise for the commercial production (i.e. expertise in the management of critical deviation).
- Provide expertise in the periodic quality review.
- Remain relevant in new business intelligent tools and become a SME in the field.
- Provide product expertise for the commercial production (i.e. expertise in the management of critical deviation).
- Work closely with MSAT Manufacturing Support and MSAT Process Science & Manufacturing Technology teams to identify and confirm critical process parameters needed for equipment and process validation.

**Audit preparation and management**:

- Participate in L2 audit, corporate and regulatory inspections and front the inspector’s questions as Subject Matter Expert.

**Project Management**:

- Lead projects related to product life cycle changes or optimization.
- Lead product investigation task forces or working groups.
- Represent MSAT department or site during technical transfer activities as required.

**Product Life Cycle Management**:

- Manage the entire lifecycle of products and processes manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products.
- Own and promote robust end-to-end product stewardship, ensuring single point of contact for products within the site and across sites for multi-site products.
- Manage end-to end process and product changes from design of the change control strategy, redaction, execution of PPQ protocol and reports to the submission of the changes. Provide justification/verification projects generate sufficient process knowledge by thoroughly testing critical variables.
- Review and release regulatory proposals or product information required for regulatory filings.
- Develop a deep product knowledge to become a recognized product expert for the site.
- Consult cross-functionally as an SME (Subject Matter Expert) on s