Operational Quality Section Head

Site Name: Egypt - Cairo
Posted Date: Oct ‎31 ‎2022

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 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
This role will provide YOU the opportunity to lead key activities to
progress YOUR career, these responsibilities include some of the following:
* Supervise and approve the release of manufactured batches to both local and export markets after review of all required documentation, ensuring that batches are released after fulfilling all GMP requirements.
* Supervise OQ officers for application of OQ measures in production areas during routine activities and validation practices.
* Revise and update quality related documents, in compliance with Corporate Standards, such as GQPs, GQGs, and GQMPs. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
* Handle investigations of deviations, complaints and OOS , OOT results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate corrective and preventive actions and ensure investigation closure within specified time with intended Quality requirements.
* Conduct self-inspection programs, follows up implementation of required actions, and follows up implementation of actions required by other audit levels and responds to L2, L3 and L4 audits in OQ department.
* Report quality performance either monthly or periodically, e.g. Site KPI 's, OQ Trends (complaints, deviations … etc).
* Escalate and communicate critical quality issues to local management, where necessary, and ensures that actions needed have the appropriate priority.
* Ensure application of OQ measures relevant to validation qualifications, change controls and exceptions handling.
* Accountable for training of Officers and the technical / personal development of his/her direct reports.
* Support GPS foundations implementation (TIPS and TAPS) and increase awareness of subordinates and make the most of using GPS tools for effective performance and on-going improvement in ways of working.
* Ensure that EHS policies and procedures are implemented during work and that all manufacturing and packaging processes are done according to GMS requirements.
* Responsible to participate in Self Inspection programme within OQ department to confirm department adherence to LSOPs and policies.
* Batch record review prior to batch release to market.
* Knowledge about SAP and QWF.
* Review & document PCCE risk assessment related to each area in the VS with appropriate controls to minimize any potential process risks.
* Handling of PCCE incidents in the VS areas.
* Responsible for and Ensure proper implementation of ALCOA+ Principles.
* Ensure proper handling of Ejects and Rejects activities in all VS areas.
* Conduct relevant microbiological risk assessments and develop effective risk mitigation plans with coordination of different stakeholders.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our
goals:
* BSC in Pharmaceutical is a must
* Min. ‎5 years of experience in similar field.
* Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
* Excellent documentation and report writing skills.
* Excellent verbal and written communication skills.
* Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
* Good command of English and computer skills.
* Self-motivation, empowerment and adaptation to business changes.
* Strong prioritization and organization skills.
* Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.
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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