Informasi Lowongan kerja : Product Owner – GSK – GSK
GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK has been operating in Indonesia and grown substantially both in its infrastructure, business operations as well as talent base spreading across its four business entities – Pharmaceuticals & Vaccines, Consumer Healthcare, Business Service Center and Consumer Healthcare Supply Chain.
We are currently looking for experienced Product Owners who are keen to lead and “own” the technical aspects of a product or product family at Pulogadung site where the product is manufactured, and to ensure that the product is delivered to the highest levels of quality and robustness
Other Key Responsibilities:
Provide leadership and establish key partnerships across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable
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, conduct Process Qualification and an appropriate means pro-actively trending performance of the product, including stability, highlighting trends to 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, utilizing the principles of the GSK Production System (GPS) and ensures that suitable cleaning validation or verification processes are in place and in use
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 other sites ensuring Quality by Design principles are applied and a robust, well understood process is transferred with a well-defined and appropriate Product Control Strategy
Provides technical inputs and 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
We look for people who appreciate the importance of safety and quality and strive to continuously improve our performance and practices. We work in an open and transparent environment so you’ll be someone who treats others with respect and integrity – as you will be treated yourself.
Ideally, we are looking for someone with :
A Bachelor degree, with at least 3 years working experience
Has detailed knowledge of relevant dosage form including unit operation understanding, manufacturing processes, plant equipment and analytical testing.
Has track record of improving products, processes and trouble-shooting.
Experienced 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 knowledge of GMP requirements, SOP’s and policies.
Demonstrates in depth knowledge and application of Quality by Design and risk management approaches.
Knowledge or experience of using statistics; Data analysis, MSA, DoE.
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