OQ Officer

Job Purpose

To ensure in-process monitoring of production and production related activities and to ensure Quality Assurance processes are implemented and used in Production Operations and Quality Operations to support producing products with respect to GSK and Regulatory specifications and bring improvement to make the processes more robust.

Education & Experience

Pharm D/MSc

At least 2 years of relevant experience

Key Responsibilities

In-Process Control:
 Ensure in-process checking during operations (oversight) are according to SOPs, understanding of
core Operational Quality processes and taking action to mitigate risk.
 Ensure that manufacturing, filling and packing activities are performed according to BMR, BPR and
relevant SOPs.
 Data Integrity & Compliance: Support in Data integrity implementation and improve the DI controls
at site.
 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.
 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 for Operational Quality including SelfInspections, SOP status, Trainings, CAPA closure, Gap analysis actions and others are timely
completed and communicated to relevant stake holders.
Validations:
 Execution of Validation Protocols and activities on floor.
 Support in site validation activities by providing OQ input.
Environment, Health & Safety:
 To ensure that EHS practices are being maintained.
 Implement and follow EHS standards and guidelines in Operational Quality.
 Reporting EHS adverse events.

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

Contact information:

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