Product Owner - Parma, Italia - GSK

GSK

Azienda verificata

Parma, Italia

4 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Italy - Parma

Posted Date:
Feb 2 2024

**_

Product Owner_**The purpose of this role is to own and provide technical leadership for a product or product family at a local and/or global level (GSK Parma site and/or across all sites where the product is manufactured), and to ensure that the product is delivered to the highest levels of quality and robustness.

In this role, you will

Be recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance, and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs); be accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
Be responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy, Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.
Ensure QbD principles are applied and a robust process/product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, and transfers to other sites.
Maintain accountability for the product throughout its lifecycle, influencing the manufacturing and analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach.
Be responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties, assessment of impact of API/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc.
Provide leadership and establishes key relationships within site across Operations, Tech, Quality and Engineering for the product(s) for which you will be accountable, and above site with other Product Owners and R&D.
Provide technical input to regulatory submissions for first file, postapproval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
Provide technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
Lead Product Technical Review Team (PTRT) if Product Owner for drug product.

Basic Qualifications and Skills:

Bachelor's degree.
Demonstrated experience in the Pharmaceutical or FMCG industry in leading the technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control.
Detailed knowledge of relevant dosage form and broad knowledge of regulatory environment, particularly in markets where product is commercialized.
Experience in technology transfer, with an understanding of the product development process.
Thorough knowledge of GMP and EHS requirements.
Demonstrated indepth knowledge of Quality by Design and risk management approaches.
Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders.
Demonstrated ability to mentor operational staff and support functions.

Preferred Qualifications and Skills:

Ability to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA

Why Us?

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregn