Assistant Manager Stability Operations

Site Name: Pakistan - Sindh - Karachi

Posted Date: Nov 21 2024

Job Purpose

To ensure that Stability studies is being carried out in compliance with QMS, cGMP, regulatory and Data Integrity requirements.

Education, Experience & Skills

• M.Sc. Chemistry
• Minimum 3-to-5-year experience of Pharma background.
• Computer literacy, minimum to access and utilize emails for official correspondence
• Use of MS-Office (Word, Excel, PowerPoint) at least to a moderate level
• Good communication and presentation skills
  
  
  

Key Responsibilities

• Ensure on time stability testing as per approved monthly schedule.
• Performing tests and documenting results according to GSK approved procedures
• To ensure Stability testing schedule adherence on monthly basis as per Monthly Stability Schedule
• To maintain Master Stability Schedule is accurately and timely prepared.
• To perform evaluation of Stability data as per Product trend.
• To make the adherence of Reporting of OOS/atypical results and deviations a part for investigation team.
• To manage maintenance and Calibration of lab equipment.
• To review Chamber monitoring data and deal with excursions as per requirement.
• To facilitate timely launching of the new Product by timely testing and evaluation of Stability profile.
• To prepare and approve Stability protocols before commencement of Stability studies.
• To Manage testing of Penicillin and Non penicillin product in safe environment by implementation of EHS policies and Procedures.
• To manage reference standard, Chemicals, reagents, and glass ware management are appropriate for Stability testing.
• To monitor department budget and KPIs as per Site Targets.
• To maintain Area GMP/GLP.
• To perform/manage timely conduct Self Inspection in the area and closure of CAPAs.
• To perform/manage revision of IFS/TM and SOPs as per requirement.
• To perform/manage timely completion of Equipment validations.
• To perform/manage timely closure of VQD CAPAs and action items
  
  
  

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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