The Quality Specialist at the Panama Regional Distribution Center (PA RDC) ensures regulatory and GSK QMS vaccines requirements are implemented and followed at PA RDC (operated by an external party).

Your Responsibilities:     

This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

• Work closely with PA RDC personnel and GSK staff at Panama to ensure continuous supply of vaccines in compliance with regulatory and GSK QMS vaccines quality requirements.
• Support quality aspect of inbound movement of the vaccine (Quality Oversight of the stock at RDC).
• Undertake Quality monitoring activities while vaccines are under GSK Vaccines ownership.
• Perform Quality Oversight of the LSP-related processes.
• Ensure PA RDC Quality System for services provided to GSK is in compliance with relevant regulations and with GSK QMS vaccine requirements/processes.
• Contribute to the review of RDC SOPs ensuring compliance with GSK QMS vaccine processes and requirements.
• Contribute to audits, change controls, deviations, CAPAs and other GSK QMS processes as applicable that are related to PA RDC operations following relevant procedures, ensuring that all issues are escalated appropriately, proper actions are defined, and quality impact is properly assessed. Ensure implementation follow up is performed.
• Implement and monitor quality KPIs for PA RDC activities in collaboration with PA RDC personnel and GSK staff.  Perform periodic review and ensure that negative trends are properly escalated to the responsible GSK Quality teams.
• Reporting of distribution related incidents that occur during distribution to GSK Bio or related activities at PA RDC (e.g. sub-batch usage decision, cold chain correction, management of TOR) Interact and align with GSK vaccines manufacturing/shipping sites as applicable, follow up & execute GSK Bio final disposition. 
• Ensure regulatory inspection readiness of PA RDC; be involved as applicable to support during regulatory inspections.
• Ensure GMP/GDP training completion and oversight quality requirements as defined in the quality agreement with the LSP.
• Ensure periodic GSK GMP/GDP audit is performed at RDC in collaboration with other GSK stakeholders.
• Oversight RDC related maintenance, validation, pest control, cleaning, and calibration plans activities ensuring documents are reviewed, handled, and approved in accordance with procedures and in a timely manner.
• Contribute to Quality Agreement lifecycle management.
• Participate in PA RDC governance meetings and project meetings as applicable ensuring QA involvement.
• Proactively identify any potential quality, regulatory and compliance risks related to PA RDC, managed via GSK system, actively work on mitigation plan and escalate in a timely manner any concerns to the appropriate authority.
• Ensure a continuous quality and compliance improvement mindset within PA RDC and across other GSK distribution centers and stakeholders by collaborating and aligning on best practices.
• Support Quality Pharma activities in the Panama Multi Market Warehouse (MMW) as per request.

 Why you?

Basic Qualifications:

We are looking for professionals with these characteristics to achieve our goals:

• Bachelor/University Degree: Degree in Sciences / Engineering e.g. Pharmacist / master’s in sciences / Bio Engineer.
• Minimum 3 years of experience in a pharmaceutical/biological production or distribution environment. 
• Direct experience with GDP regulated environment within major authority jurisdiction (DNFD/ COFEPRIS /INVIMA/DIGEMID/ WHO Audit)
• Substantial knowledge of regulatory, GMP, GDP and legal requirements related to QA.
• In depth knowledge of regulations, guidance, and industry standards related to the systems (for example: GSK, GMP, GDP, WHO, PDA, ASTM, ISPE, PhRMA, IATA, GAMP, etc.)
• Strong technical and quality knowledge of distribution related technologies and technical services processes such as validation, maintenance, calibration, and measurement.
• Advanced level in English & Spanish, written and spoken.

Preferred Experience:

However, if you have the following, it would be a plus:

• Knowledge and expertise of SAP and quality systems, e.g. Deviation, Documentation Management, Training, Change Control, CAPA, Risk Management, Validation.

If you feel this is your next career move, please apply up to August 13, 2024.

Why GSK?

Our values and expectations are at the heart of everything we do and define our culture so that together we can deliver extraordinary impact for patients and consumers and make GSK a brilliant place to work.

As a GSK employee you will be encouraged to be you in a diverse and inclusive environment that focus on your wellbeing and enables you to feel good and to thrive, and gather the opportunities we offer to learn, develop and keep growing.

At GSK we believe that we all bring something unique and when we combine our knowledge, experiences and styles together, the impact is incredible. Join us to make the difference and play an important role on the benefit of millions of patients and consumers worldwide.

Why GSK?

Uniting science, technology and talent to get ahead of disease 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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