Job Purpose
The purpose of this role is to deliver the Oral Solid, Powder, Liquid, Intravenous, Cream & Ointment dosage product portfolio, including new product introduction, and complex changes to existing products, input materials, processes, equipment technologies and manufacturing sites to meet business demands. To own and provide technical leadership for a product or product family at a local (site) and/or global level (across all sites where the product is manufactured), and to ensure that the product is delivered to the highest levels of quality and robustness. To support PLM deployment at Site. Support on statistical analysis and statistical capability building in ES India.
In this role you will
- Ensure day to day technical issues are resolved urgently to minimize reject/waste levels. 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. Actively facilitate the improvement of process capability, product quality and batch yields across the supply chain.
- Responsible for the technical aspects of product quality and knowledge transfer. Recognized as the principal point of contact for technical aspects of a product to drive discussions at PTC.
- Responsible for acquiring and maintaining product knowledge expertise, and knowledge management of products throughout lifecycle.
- Responsible for the technical aspects of the new product introduction to hand over to production. Responsible for supporting the product transfers to sister GMS sites and third-party contract manufacturers.
- Responsible for providing technical leadership into complex launched product performance investigations. Support the introduction of highly capable new process technologies and improvement of process capability of existing unit processes. Provide technical packaging support in response to site LICs & PIRCs, Quality notifications, CAPAs and internal audit findings.
- Responsible for approving and resourcing technical aspects of planned changes for launched products through effective risk management processes. Responsible for ensuring all aspects of Product Lifecycle Management are in place and actively maintained for the product(s).
- 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.
- 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 (primary product owner), assessment of impact of API/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), etc.
- Provides leadership and establishes key relationships within sites across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
- Provides technical input to annual reports, Periodic Product Reviews and internal and external audits.
Why you?
Basic Qualifications: - M. Pharm. with a minimum of 10 years of experience or Ph.D. with a minimum of 5 years of experience Technical Function in Pharmaceutical Industry
- Experience in interactions with Senior Leaders (Regional Supply Chain Heads, Senior Management at Site) requires a high level of understanding of complex cross functional challenges that need to be managed appropriately and routinely solved.
- Knowledge of digital tools is preferred
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
