Process Expert Production



Karachi, Karachi City, Sindh, Pakistan
Posted on Friday, June 7, 2024

Job Purpose

To ensure implementation of the operational plans assigned, in compliance with the objectives set in terms of quality, safety and efficiency. It contributes to the Process Robustness, Continuous Improvement, Complex Problem Solving and Life Cycle Specific Improvements. To ensure Sterile processing and facility design standards remain current with regulatory standards and GSK expectations working across the site and with regional team to influence and promote industry leading standards at the Korangi site.

Education, Experience & Skills

  • 5-8 years of experience in a similar role

  • Pharm-D Or M Phil (Pharmaceutics)

  • Knowledge and understanding of principle regulatory standards and guidelines applicable to manufacturing with demonstrated ability to solve complex problems especially associated with sterile products/processes

Key Responsibilities

  • Ensure site sterile processing standards, including facility design, are reflected in the site strategy and key project plans so as to maintain compliance with current and future regulatory standards (where possible) and GSK QMS and risk model requirements.

  • Work in concert with the cross functional and regional teams so as to provide first hand experience and knowledge back to site of current industry best practice and innovations.

  • Train and mentor site personnel across departments to maintain a strong sterile manufacture capability

  • Participate in complex deviation investigations and change management reviews where a high level of manufacturing technical expertise is required.

  • Provide innovative solutions to promote and improve manufacturing operational simplification, robustness and efficiency to address product portfolio changes and toll manufacturing.

  • Represent the site in updates to QMS policies, processes and technical standards, where appropriate.

  • Front sterile manufacture topics during site inspections and audits demonstrating strong knowledge and understanding of leading regulatory requirements, where appropriate.

  • Provide technical leadership for the products manufactured at Korangi and to ensure that the product is delivered to the highest levels of quality and robustness.

  • Work with MSAT to drive continuous improvement initiatives for robust product life cycle management and product/process performance.

  • Assist Site Production Lead in defining the manufacturing strategy to ensure sufficient quantities of quality products at or below budgeted production costs are produced in order to meet marketplace demand and third-party business.

  • Resolves strategic allocation issues related to the organisation's production, machinery, processing and/or packaging operations.

  • Support in implementation of material changes driven from de-risking and PPV.

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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