MSAT Product Expert

Site Name:
Singapore - Tuas
Posted Date:
Dec 18 2024
Are you looking for an opportunity to support the global supply chain working with batch records and determining root cause analysis of standard operating?
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.
Apply KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
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.
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.
Support and where appropriate lead optimization of pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies.
Develop a deep product knowledge to become a recognized product expert for the site.
Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
Committed to knowledge sharing/transfer inside sites, other MPUs as well TRD.
Write, review, and revise SOPs (Standard Operating Procedures).
Report Product Impact assessment in process deviations when they occur.
Coordinate/lead product task forces with representatives from other departments.
Ensure the robustness of manufacturing processes so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
Maintain up to date consolidated PLM (Product Lifecycle Management) plans.
Own and actively manage the Product Improvement Portfolio (PIP) allowing for prioritization and ensuring cross-functional contribution, as necessary.
Analyze all assigned areas of operations for potential improvement opportunities and makes applicable recommendations for process, system, procedure, and operational changes to improve operations and quality.
Apply appropriate change management methods to promote implementation of technology changes. Facilitate organizational change by helping to prepare personnel to accept and actively participate in new changes, through communication, coaching, and educational workshops.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
A bachelor's degree in engineering and/or Science with 5 - 8 years’ experience cGMP-related commercial / clinical manufacturing / R&D experience.
Scientist or Engineer with relevant experience in polysaccharide-based Vaccines processes.
Advanced science degree in data analytics or similar field is an asset.
Understands databases and SQL.
Strong MS Office background (Excel, Word, Project, PowerPoint, Visio, etc.).
Have strong trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.
Have excellent written and verbal communication skills.
Quantitative & qualitative analytical skills.
Strong project management, planning, organizational skills desired.
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