Site Name: Pakistan - Sindh - Karachi
Posted Date: Sep 5 2024
Job Purpose
Responsible for validating equipment, systems and utilities which include SAT, DQ/EDR, IQ, OQ ensuring compliance with regulatory requirements and QMS including CSQMS, periodic compliance/validation reviews and maintenance of validation documentation as per GSK validation policies.

Education, Experience & Skills

• B. E (Industrial/Chemical/Mechanical/Electrical)
  
• 3-5 years relevant experience
  
• Technical Acumen (Thinking, Reasoning, Logic)
  
• Excellent building relationship ability to establish effective relationships at all levels across the organization
  
• Strong teamwork with an ability to interact with people across all functions and levels within the organization
  
• Communication Skills and Change Management
  
• Influencing skills required to coordinate departmental and interdepartmental activities (e.g Engineering & EHS alerts, trainings, Validation Life Cycle and risk management etc.) Matrix working required to keep the department align with various stakeholders e.g. EHS Manager, Site Leadership team and areas as required.
  
• Technical: Understanding of Quality Management Process, GSK policies, Auditing approach and good documentation practices. Business: Effective communication and report writing skills.
  
• Competencies: Validation as per Regulatory requirements, Analytical thinking skills, problem solving and RCA, leadership skills.
  

Key Responsibilities

• To ensure Computerized System Validation at site which includes Kneat, CSQMS and Periodic Compliance Review.
  
• To prepare and perform Periodic Compliance Review and Periodic Validation Review of all the Gx P equipment and utility system.
  
• To ensure all the Gx P and Non-Gx P production equipment, utilities systems and facilities are commissioned and qualified as per approved protocols and reports.
  
• To update validation tracker and to keep validation activities in track and as per SVMP schedule.
  
• To ensure that the documentation in terms of SAT, DQ/EDR, IQ and OQ protocols and their validation reports are timely prepared.
  
• Lead New Validation which includes URS, SIA, RTM,DQ/DR, CVP/IOQ protocol and Validation Report .
  
• To track and keep informed to Site Engineering Lead that all facilities, equipment, and operations at site validation are in line with regulatory and corporate requirements.
  
• Be a member of validation working party (VWP) for follow ups of validation targets as per defined timelines and discuss and resolve issues raised relevant to various activities with VWP.
  
• Ensuring that all the validation documentation is complete and prepared as per validation policies and guidelines and are easily accessible.
  
• Responsible for complete documentation and record keeping of Validation and CSV documents
  

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:
You may apply for this position online by selecting the Apply now button.

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