Posted Date: Dec 18 2019
This is a key leadership role and Solid Topical 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.
- Solid Topical Product Owner is highly knowledgeable about both the current status and history of the Solid & Topical products, is recognized as the principle point of contact (‘go to’ person) for the end to end process, for all aspects of current and previous knowledge and performance.
- Solid Topical 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, 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 suitable cleaning validation or verification processes are in place and in use.
- 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).
- 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 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 input into root cause analyses to support the investigation and resolution of product complaints and product deviations and investigations, in conjunction with Quality Assurance.
We are looking for who you with below attributes.
- Minimum in Bachelors Degree with 5 years experience in related field.
- 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.
- Demonstrates ability to contribute to and effectively influence matrix teams and colleagues in other functions.
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