Site Name: Egypt - Cairo
Posted Date: Jul ‎20 ‎2022

Are you a Manufacturing Professional looking for a challenging opportunity to
drive Quality Management System improvement and simplification for your local
region while working with Quality Managers across the globe? If so, this could
be a great position for you to explore.
As an Operational Quality Manager/Lead, in conjunction with the Site Quality
Director and Value Stream Manager, you will be responsible to evaluate future
business needs (e.g. Site Business Plan and Regulatory Intelligence) and
agree/design a strategy to ensure the Operational Quality Section meet these
needs. You will drive change by delivering the strategy via means of culture
change, new technologies, organization change and ways of working, ensure that
products released for sale have been manufactured and packaged, in accordance
with the licensing requirements, Good Pharmaceutical Manufacturing Practice
and business requirements, and promote quality/compliance within the Product
Streams, In addition, you will ensure that Products are available on time,
complying with policies and standards, and exceed customer expectations.
This role will provide YOU the opportunity to lead key activities to progress
YOUR career, these responsibilities include some of the following:
* In line with the requirements of the Value Stream Leader provide an effective product release
service which ensures that all products released for sale or further
processing have a quality
appropriate to their Intended use, i.e. comply with the export market, local
Egyptian and
Company GMP Standards and Product Quality Specifications.
* Ensure Quality Incidents associated with products manufactured and packed with In the Value
Stream are managed in line with the QMS and local procedures. Manage LIC,
PIRC, Recall functions In coordination with Site Quality Head.
* Ensure that there is effective management of investigations (including CAPA) and assessment of
data from products failing to meet requisite standards and make batch
disposition decisions on rejection or rework in consultation with the Site
Quality Director , Value Stream Manager and Site Director as appropriate.
* Influence Quality Improvement programs (QIP )and work with the appropriate Value Stream
Manager and technical colleagues with the aim of reducing rejects and customer
complaints and
In doing so achieve a right first time/by first intent culture.
* Handle investigations of deviations, Data integrity deviations, complaints, OOS & OOT results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate CAPA & ensure investigation closure within specified time with intended Quality requirements
* Manage the Quality and where appropriate the Technical interfaces between the Site and Auditors during Audits.
* Sign-off the Stream Periodic Product Reviews.
* As appropriate manage the Quality sign off/approval of all quality related systems, procedures and documentation utilized within the Value Stream and ensures compliance with and Company GMP Standards (i.e. QMS) and Product Quality Specifications.
* Ensure that any changes raised for Value Stream manufactured and or packed products have been appropriately validated and documented using the Site systems of approval. Manage the Quality Function sign off for Stream related Change Control Requests
* Manage an effective Quality Team aligned to Product Stream by promoting a culture of task delegation and single touch 'ways of working.
* Be responsible for technical and personal development of direct reports by using effective appraisal and performance management and implement training for Operational Quality staff to ensure competence In performing their required function.
* Provide GMP advice to the Value Stream on an ongoing basis, as required and promote safety awareness by all Operational Quality staff.
* Deputize for the Cairo Quality Site Head as required and investigate counterfeit Incidents with proper escalation in coordination with Site Quality Head.
* Ensure Annual review reports/trends are prepared, reviewed and Issues have been escalated and necessary actions have been taken ex: deviations, complaints, OOS, OOT.
* Increase awareness of subordinate and make the most of using GPS tools for effective Information search 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 per GSC requirements.
* Manage Documentation life cycle management and ensure that data integrity requirements are followed.
* Responsible to participate in Self Inspection program within OQ department to confirm department adherence to LSOPs and policies with adequate follow-up actions.
* Review and approve PCCE risk assessments related to each area in VS with appropriate controls to minimize potential product Quality risks.
* Review and approve Ejects and Rejections risk assessment each machine in VS with appropriate controls to minimize potential product Quality risks and complaints.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our
goals:
* Bachelor's degree in Pharmaceutical Sciences.
* Minimum ‎7 years of experience in Operational Quality or Operations within the pharmaceutical industry.
* 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 and equipment, with solid experience in cGMP/GLP compliance activities.
* Experienced in handling regulatory interfaces such as inspections.

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.

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