Manager MSAT - Karachi, Pakistan - GSK

Description

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.

Informações de contato:
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