Local Operating Company “LOC” Quality Executive

Site Name: Egypt - Cairo
Posted Date: Jun ‎19 ‎2022

Job Purpose
The Local Operating Company "LOC" Quality Executive roles exists to provide
effective and efficient quality assurance systems support to the Local
Operating Company "LOC "Quality Manager or Local Operating Company "LOC"
Quality Area Lead, including supporting the implementation and maintenance of
the Quality Management System "QMS" and as directed by the LOC Quality Manager
performs the day to day work to ensure that the quality systems required by
the LOC element of the Supply Chain and Marketing Company Local Operating
Company "LOC" are performed in a lean and efficient way and meet the
compliance standards of the QMS and the local Regulator.
The Local Operating Company "LOC" Quality Executive will act as Quality
Representative within the Commercial Team supporting the delivery of quality
management system for the nominated area or country. The role holder will also
partner with the business to ensure that their business requirements are
understood. The role will take supporting role to drive a quality culture
within the Local Operating Company "LOC"s. The role will drive standardized
business processes where applicable across Local Operating Company "LOC" to
maximize business benefits
Key Responsibilities:
‎1. Maintain a high level of Quality Management System "QMS" knowledge and
awareness of changes within the commercial environment to seek opportunities
and manage potential business adversity.
‎2. Act as the relevant Local Operating Company "LOC" quality contact for the
Regional Quality organization providing communication to the regional quality
organization on progress on Quality Management System "QMS" compliance status
updates on quality plans and escalation of issues. Share learning's and issues
appropriately with other Local Operating Company "LOC" and regional
colleagues.
‎3. Support the implementation and maintenance of effective Quality Assurance
systems to ensure that local operations are in full compliance with GSK
standards and policies, Guide for Commercial Companies, Good Manufacturing
Practice "GMP", Good Distribution Practice "GDP" and regulatory requirements
by supporting the Local Operating Company "LOC" Quality Manager as directed
* Ensure that all Standard Operating Procedure "SOP"s are in place, updated & training has been conducted across the GxP business processes. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to Standard Operating Procedure "SOPs as relevant.
* Promote Quality Management System "QMS" management principles and seek continuous improvement of the processes
* Review, conduct impact assessments and implement any updates to Quality Management System "QMS" policies
* Manage QMS Management Review meetings according to local Standard Operating Procedure "SOPs"
* Identify, Implement and Manage QA Objectives & KPIs
* Establish and manage Annual Quality Plans
‎4. Support the Local Operating Company "LOC" Quality Manager to ensure that
all internal procedures and systems in use in the Local Operating Company
"LOC" are compliant to GSK Quality Management System "QMS", Guide for
Commercial Companies and local regulatory requirements, including (but not
limited to):
* Local Operating Company "LOC" Quality Council - support the LOC Quality Manager re organizing Council meeting with regular meetings. This support should ensure that the Local Operating Company "LOC" Quality Council format, frequency and reporting are standardized to global requirements. In addition, support should be provided to ensure Quality metrics and reporting format/ system in place.
* Change Control - perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.
* Risk Management - perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
* Corrective and Preventative Actions "CAPA" - Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop Corrective and Preventative Actions "CAPA's". Local process in place to track and review Corrective and Preventative Actions "CAPA" plans on routine basis. Demonstrate that Local Operating Company "LOC" effectively identifies where Corrective and Preventative Actions "CAPA" plans required and that they are effectively implemented, monitored and closed out.
* Auditing - perform day to day work to support the local process that is in place for Level ‎1 (self-inspection) and Level ‎2 monitoring auditing.
* Work with the Local Operating Company "LOC" Quality Manager to ensure:
* The Level ‎1 and Level ‎2 auditing process includes clear accountability for sign off of audit reports and resultant Corrective and Preventative Actions "CAPA"/ Risk management.
* Level ‎1 and Level ‎2 audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
* There is a process in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by either Local Operating Company "LOC" QA Team or the appropriate Central Team (e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, activation agencies
* Close follow up on Logistica service provider " LSP" to ensure that GDP is fully implemented.
* Availability if requested to participate in Level ‎1 (self) and Level ‎2 audits with the agreement of the relevant Central Team
* The Local Operating Company "LOC" element of the Supply Chain and the Quality elements of the Marketing Company are audit ready for any relevant Level ‎3 or ‎4 audits
* Complaints - perform day to day work to support an effective complaints management process ensuring the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate. Report and follow up on product complaints with manufacturing sites, customers and commercial teams.
* Incident management - Support the Local Operating Company "LOC" Quality Manager to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global Product Incident /Recall Committee "PIRC" process. Assist the Local Operating Company "LOC" Quality Manager in any investigations triggered by local incidents and in conducting Local Operating Company "LOC" Incident Committees.
* Product supply - performs day to day work to support systems that have an impact on the quality of imported, products in line with the Quality Management System "QMS" and local Regulatory requirements
* Artwork process oversight - perform Artwork "AW" KPIs improvement in line with the roles and responsibilities for quality as defined in the artwork procedures.
* Local Repacking - perform day to day work to support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples.
‎5. Maintains all quality documentation such as product specifications and
Standard Operating Procedures in accordance with GSK policies.
* Ensures all product specifications and related documents (e.g. CoAs, TTs) are maintained compliant to current registered details.
* Maintains and updates the QA Standard Operating Procedures
Why you?
Basic Qualifications:
Education and Experience:
* Degree in a Science or related discipline (Chemistry, Pharmacy, Biology …).
* Total ‎5 years' experience within pharmaceutical industry and application of Quality System
* High level of GMP/GDP knowledge
* Exceptional leadership skills
* Excellent oral and written communication skills
* Proven influence and impact skills across business levels and functions
* Strong interpersonal and negotiation skills
* Problem identification and solving skills
* Ability to enable and drive change
* Able to work effectively in English
* Self-starter, able to schedule and progress workload on own
Why Consumer Healthcare?
Right now, we 're on an incredible journey as we prepare to become the first
independent, ‎100% focused consumer healthcare company. We're doing this at a
time when the work we do has never mattered more. Better everyday health is
about improving the health and wellness of the consumers that we touch every
year - over a billion and a half of them - and it goes beyond products. It's
about truly helping people manage their health proactively in different ways
as consumer needs evolve.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on
trusted science and human understanding, and combined with our passion,
knowledge and expertise, we're uniquely placed to do this and to grow a
strong, successful business. This is an exciting time to join us and help
shape the future. It's an opportunity to be part of something special.
Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an
inclusive environment that celebrates our unique perspectives, generates
curiosity to create unmatched understanding of each other, and promotes fair
and equitable outcomes for everyone.
We're striving to create a climate where we celebrate our diversity in all
forms by treating each other with respect, listening to different viewpoints,
supporting our communities, and creating a workplace where your authentic self
belongs and thrives.

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