Stability Analyst

Job Purpose

You will support stability testing and related laboratory activities to help ensure product quality and safety. You will work closely with laboratory colleagues, equipment technicians, and quality teams. We value accuracy, a curious mindset, and the willingness to learn and improve processes. This role offers hands-on experience, clear career growth, and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities:

• Ensure timely stability testing in accordance with the approved monthly schedule for both Penicillin and Non-Penicillin products and adhere to weekly and monthly stability schedule.
• Perform tests and document results in compliance with GSK-approved procedures.
• Participate in investigations of Out-of-Specification (OOS) and atypical results and Identify/observe gaps and proceed as per the QMS requirement.
• Ensure that issuance or reconciliation of Control prints are effectively managed through VQD System for maintaining traceability and compliance.
• Maintain the record of analytical results in logbook and maintain instrument checking and calibration records.
• Update monthly temperature and humidity monitoring records.
• Adherent to Environmental, Health, and Safety (EHS) standards and guidelines to ensure a safe working environment.
• Review and analyze stability data trends, raw data, and maintain analyst logbooks and
• Laboratory Information Management System (LIMS) reports.
• To review Chamber monitoring data and communicate the anomalies identified to supervisor.
• Perform Management monitoring as per requirement and ensure timely closure of actions in VQMS.

Education, Experience and Skills

• M.Sc Chemistry or Pharm-D or equivalent
• Minimum 2 - 3 years of relevant experience in stability testing or analytical laboratories.
• Practical experience with analytical instrumentation such as HPLC, GC, UV/Vis or equivalent.
• Familiarity with regulatory requirements and quality systems, including GMP and data integrity principles.
• Good computer skills including MS Office and basic use of laboratory information systems.
• Hands-on experience with equipment validation and calibration activities.
• Experience with stability chamber monitoring and managing excursions.
• Prior use of LIMS for sample tracking and data reporting.
• Understanding of investigations, root cause analysis and CAPA processes.
• Training or exposure to continuous improvement approaches such as Lean or Six Sigma.

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

 

 

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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

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