Manager MSAT

Job Purpose

• Provide technical leadership for the products manufactured at F268 and to ensure that the product is delivered to the highest levels of quality and robustness.
• Provide technical expertise and support in implementation of packaging solutions at site.
• Provide support in assessing and managing Material Source Change process at site.
• Provide support in New Product Introduction at site.
• Provide support in product transfer activities to and from sister GMS sites and 3rd part contract manufacturers.

Education, Experience & Skills

• Graduation/Professional degree in Sciences (Pharmacy, Chemistry etc.)
• 5-7 years’ experience in operations, laboratory or similar functions with understanding of process chemistry, analytical development, and process engineering.
• Good verbal & written communication skills
• Analytical thinking and problem solving

Key Responsibilities

• Be 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 and globally as appropriate.
• 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 as per the principles of GPS), Continued Process Verification and Periodic Product Reviews (PPRs).
• 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.
• Lead process improvement projects on site, ensuring appropriate technical change control to deliver robust, sustainable solutions.
• 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 impact of API/excipient changes on the dose form via the Material Risk Assessment process (MRA)
• Provides technical leadership and input into root cause analyses (RCA) to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
• Support in managing the risk management activities to ensure business risks are timely identified & mitigated. Also coordinate Business Continuity Planning for the site.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:

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