Key Responsibilities :

- Provide efficient, effective and compliant technical support to the Product Stream manufacturing processes and activities in alignment with technical groups based within the Product Stream, and coordinate technical activities.

- Preparation and execution of NPD trials, RM evaluations, validations and planned changes to agreed timescales.

- Actively facilitate the improvement of product and process capability and batch yields .

- Ensure day to day technical issues are resolved urgently to minimize reject/waste levels and improve overall quality of the products.

- Responsible for acquiring and maintaining product knowledge expertise, and knowledge management of products throughout lifecycle.

- Promote and monitor technical standards throughout the product stream and ensure they are adhered to.

- Responsible for ensuring appropriate systems to track, trend and analyze product performance are in place.

- Responsible for applying product performance targets to products post launch.

- Responsible for the technical aspects of new product introduction to hand over to production.

- Responsible for approving and resourcing technical aspects of planned changes for launched products through effective risk management processes.

- Support the introduction of highly capable new process technologies and improvement of process capability of existing unit processes.

- Recognised 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). Accountable at site level for maintaining this knowledge and sharing on site.

- 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 (and translation to standard work as batch manufacturing instructions), Continued Process Verification and Process Robustness Assessment. Ensures 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.

- Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.

- Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.

- Provides 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.

- Identifies, develops and trains successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.

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