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19/06 Jyotsna Edlin
TA Team at GSK

Views:11127 Applications:244 Rec. Actions:Recruiter Actions:11

GlaxoSmithKline - Technical Product Owner (2-5 yrs)

Sonipat Job Code: 585018

Technical Product Owner-Sonepat

Job Description

Job Title: Technical Product Owner

Department : GMS

Reports to: Site Technical Lead

Location: Sonepat

Job Purpose:

The principal purpose of this role is to - own- and lead the technical aspects of a product or product family at a local (site) or global (across all sites where product is manufactured) level and to ensure that the product is delivered to the highest levels of quality and robustness.

Key Responsibilities:

- This is a key leadership role and the Product Owner is expected to provide leadership and establish key partnerships across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable

- The Product Owner is highly knowledgeable about both the current status and the history of the product/s for which he/she is accountable, is recognized as the principal point of contact for the end to end process, including packaging and cleaning, for all aspects of current and previous knowledge and performance

- The Product Owner is responsible for ensuring all aspects of Product Quality Lifecycle Management are actively applied to the product(s) including a current Technical Risk Assessment, current Product Control Strategy and an appropriate means proactively trending performance of the product, including stability, highlighting trends to the site quality council and making recommendations for continuous improvement

- Ensures that standard work is in place to translate the Product Control Strategy into clear manufacturing instructions, utilising the principles of the GSK Production system

- Accountable for the technical input to the lifecycle validation approach for the product

- Provides technical leadership on behalf of the site during technology transfer of products into GMS from R&D and subsequent transfer out to the other sites ensuring Quality by Design principles are applied and a robust, well understood process sis transferred with a well-defined and appropriate Product Control Strategy

- Provides technical input to regulatory submissions for first file, subsequent post approval submissions and annual reports

- Provides technical product advice to key stakeholders and relevant production managers ensuring that Operators have appropriate product knowledge and training to fully execute the manufacturing instructions

- Is involved in the assessment and management of all aspects of post-approval change to ensure that product quality is maintained and the appropriate change controls are in place

- Provides technical leadership and inputs into root cause analysis to support the investigation for resolution of product complaints an product deviations and investigations in conjunction with QA

Experience :

- Minimum level of education - Graduate - (B.Tech in Food/Dairy/Chemical/Industrial/Process Engineering)

- Maximum level of education - Post graduate

- Demonstrated experience in the FMCG, Food or pharmaceutical industry in leading the technical aspects of the product lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, pro-active data trending, Validation and change control

Broadly we are looking for B.Tech in Food/Dairy/Chemical/Industrial/Process Engineering have 2+ years of experience in FMCG, Food or pharmaceutical industry in leading the technical aspects of the product lifecycle.

Knowledge & Skills :

Detailed knowledge of relevant dosage form notably unit operations understanding, formulation science, packaging processes and analytical testing,. Support the technical lead in technology transfer, with an understanding of the CH new product development process. He or she should also have a track record of effective deployment of core Six Sigma statistical techniques such as Measurements System Analysis, Quality Function Deployment, Design of Experiments.

- Detailed knowledge of relevant dosage form notably unit operations understanding, device/packaging processes, plant equipment and analytical testing

- Has track record of improving products, processes and trouble shooting

- Experiences in technology transfer, with an understanding of the product development process

- Able to evaluate potential innovative technology areas relevant to product

- Proven track record of expertise in delivery of technical risk assessments

- Has thorough requirement of GMP requirements, SOPs and policies

- Demonstrates in-depth knowledge of using statistics: data analysis, MSA, DoE

- Demonstrates ability to contribute to and effectively influence matrix teams and colleagues in other functions

- Provides lead site input to technical risk assessment in support of process change and product lifecycle management

- Provides technical leadership to product failure investigations, ensuring that appropriate standard tool such as TRA, RCA are used, CAPAs are developed and implemented

- Deploys complete suite of technical skills such as Multivariate Analysis, Product Performance Analysis to ensure process understanding, control and capability is enhanced

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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