Job Purpose

The purpose of the project trainee role is to support and organize tasks assigned by the Operational Quality Manager and collaborate with other functions within the industry of GSK to drive performance.

Education, Experience & Skills

• Pharm D is required
• 0-1 Year of experience is required.
• Proficient in use of Windows and Microsoft Office Suite (especially PowerPoint, Excel and Outlook).
• Strong written and verbal communication.
• Strong problem-solving and critical thinking abilities.

Key Responsibilities

• Perform in process checks during production operations (oversight) according to SOPs and standard pack specifications and collect samples accordingly to comply with GSK specifications.
•  Collect the reference, retention, stability, and validation samples of the released products as per plan, when required.
• Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and relevant SOPs.
• Execution of Validation Protocols & support in site validation activities and activities on floor.
• Support in Data integrity implementation and improve the DI controls.
• Product Release: Support in compilation and review batch documents and release products to ensure that manufacturing, filling and packaging activities are performed according to BMRs, BPRs and relevant SOPs and ensure that batch dossiers are retained as per local regulatory and GSK record retention policy, if required.
• To confirm that all documents required are received on time and after completion, reconciliation of finished products is done as per GSK specifications and ensure data integrity.
• Verification of Line Clearance process as per defined procedure.
• Site Archive Room, Batch Document Room & Retained Sample Room: Ensure that compliance related documents are retained as per GSK record retention policy and ensure that batch record & retained samples are stored, archived and traceability of the documents and retained samples are managed.
• Deviation Handling: Report deviation and support in rectification of deviations from cGMP or the Quality Management System, providing advice to line management to ensure that cGMP compliance requirements are built into the site's core practices and ensure that product quality issues are correctly investigated, and that appropriate corrective and preventive actions are implemented.
• Investigation Handling: Support in investigations of products failing to meet standards, support and coordinate with stake holders for the CAPA preparation.
• CAPA Plan Handling: Ensure all QMS requirements are timely completed and communicated to relevant stake holders.

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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