Operational Quality Section Head

Site Name: Egypt - Giza - Giza
Posted Date: Feb ‎6 ‎2023

Are you an Operational Quality Section Head who is energized by the
challenge of being part of one of the leading pharmaceutical companies
worldwide? If so, this role is the one for you to explore.
As an Operational Quality Section Head, you will be responsible for
following up application of OQ measures in production areas during routine
activities and validation practices, handling investigations related to
different quality incidents and reporting quality performance and product
reviews periodically. You will be monitoring all work activities in the
sterile area assuring compliance with GSK standards and GMP regulations and
fulfilling Sterile area Manufacturing & filling plans.
This role will provide YOU the opportunity to lead key activities to
progress YOUR career, these responsibilities include some of the following:
‎1- GMP
* Revise and update quality related documents, in compliance with Corporate Standards, such as GQP's, GQG's, GQMP's & FPG's. This includes batch manufacturing and packaging documents, specifications, SOPs.
* Escalate and communicate critical quality issues to local management, where necessary and ensures that actions needed have the appropriate priority
* Ensure application of GMP measures relevant to validation qualifications, change. controls and exceptions handling
* Support Value stream from Quality prospective in achieving the supply goals.

‎2- Sterile Oversight / Third Party / CMO / Central Team Mngt
* Ensure Deployment of GSK Guidelines / Annex Within Sterile Area
* Manage Improvement Plans and Communications with Third Party
* Oversight CMO, Deviations, Complaints, compliance to GSK requirements
* Coordinate Quality operations and compliance with Third Party and central Team

‎3-Deviations
* Ensure proper initial response for handling investigations of deviations, complaints and OOS results, in coordination with production supervisors and ensures implementation of appropriate interim, remedial, mitigation actions.
* Ensure proper handling of deviations, complaints and OOS by OQ team
* Ensure that EHS policies and procedures are implemented during work.
‎4-Release
* Delegate of Head of Quality in regard to product review - approval for release.
* Management of quality director release handling measurement.
‎5-Management
* Supervise OQ Inspectors for application of OQ measures in production areas during routine activities and validation practices.
* Increase awareness of subordinates and make the most of using relevant tools for effective Information search and on-going improvement in ways of working.
‎6-Other functions:
* Conduct self-inspection programs, follows up implementation of required actions and follows up implementation of actions required by other audit levels.
* Report quality performance either monthly or periodically, e.g. Quality Index, OQ Trends (complaints, deviations, NRFT... etc) and Periodic Product Reviews.
* Maintain supply adherence through day to day follow up of product release and
* Ensure the appropriate measures are in place.
* Prepare/conduct the quality council meeting on behalf of head of the quality.
* Management of LIC on behalf of head of quality to co-ordinate initiation, discussions, assessment and final disposition with closure according to GQMP requirements.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* Bachelor 's Degree in in pharmaceutical sciences
* Minimum ‎4 -‎5 years of experiences in similar role.
* High Experience in Sterile area
* Supervisory, problem solving and report writing skills
* Communication skills and team working spirit
* Good knowledge of ISO, GLP and GMP regulations
Why GSK?
At GSK, we have already delivered unprecedented change over the past four
years, improving R &D, becoming a leader in Consumer Health, strengthening our
leadership, and transforming our commercial execution. Now, we're making the
biggest changes we've made to our business in over ‎20 years. We 're on track
to separate and create two new companies in ‎2022: New GSK with a leading
portfolio of vaccines and specialty medicines as well as R&D based on immune
system and genetics science; and a new world-leading consumer healthcare
company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science,
talent and technology to get ahead of disease together - all with the clear
ambition of delivering human health impact; stronger and more sustainable
shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all
this is through our people and our culture. A culture that is ambitious for
patients - so we deliver what matters better and faster; accountable for
impact - with clear ownership of goals and support to succeed; and where
we do the right thing. So, if you 're ready to improve the lives of
billions, join us at this exciting moment in our journey. Join our challenge
to get Ahead 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. Getting
ahead means preventing disease as well as treating it, and we aim to impact
the health of ‎2.5 billion people around the world in the next ‎10 years.
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:
You may apply for this position online by selecting the Apply now button.
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