Validation Coordinator - #24828

GSK


Date: 3 weeks ago
City: Jeddah
Contract type: Full time
Site Name: Saudi Arabia - Jeddah
Posted Date: Feb 7 2024


GSK Saudi Arabia is committed to supporting Vision 2030 and the Saudi Arabian National Agenda including Saudization in line with the hiring and the training and development of Saudi National capability.

Are you a Validation Coordinator who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, a Validation Coordinator role is the one for you to explore.

As a Validation Coordinator, you will coordinate validation activities with conjunction with site validation lead/Manager which will help ensuring that all operations relevant to change control & validation are undertaken following the appropriate Regulatory (SFDA) guidelines, GMP Standards, QMS requirements and relevant local standard operating procedures.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Key Responsibilities:

  • Coordinates Validation activities in general i.e. Validation of manufacturing processes, cleaning procedures, Lab & production equipment, engineering facilities, utilities, production control systems & Computer systems at Site & ensuring that all the elements of validation life-cycle approach i.e. Planning & Requirements, Design, Testing, Reporting, Use & Decommissioning Phases are in place & in use. Prepare validation weekly & monthly plan to prioritize work.
  • Facilitate various validation activities with engineering, production and quality personnel as requested by the validation lead. Create & maintain effective validation tracker to support site validation activities.
  • Maintain & follow-up lab equipment qualification & calibration plan & status
  • Prepares and/or review validation documentation for departments & projects (Master Plans, Protocols, and SOPs) as per current company policies & regulatory guidelines.
  • Participate inter-GSK site & GSK functions project and activities. Review Validation Master Plans for departments and projects when required. Liaises with departments for validation status/requirements.
  • Responsible for maintaining system validation status by issuing site validation review plans & performing or coordinating periodic system reviews (as directed by Validation Lead).
  • Assist in the implementation of Product Life Cycle management through Process Validation & Continued Process Verification at site.
  • Ensure re-validation of system as required.
  • Develop Validation department KPIs in conjunction with Validation lead to measure performance. Providing necessary validation metrics on a monthly basis to Validation lead for reporting this and other validation issues as inputs to QCM.
  • Review validation procedures timeously and accurately to cover the validation of systems by ascertaining current industry requirements, GSK requirements (GSK QMS, GSOPs relating to computerized systems, ETCM, CAP etc.).
  • Perform self-inspection (L1) audits and manage outcomes (findings) timely to prevent repeat occurrences. Prepare CAPAs of L1 audits in conjunction with Validation Lead.
  • Facilitate CAPEX projects with all stakeholders as per site requirements.
  • Ensuring adequate training and development for self on validation and other related pharmaceutical systems and processes are in place and ensuring that this training is recorded. Maintaining training records for self.
  • Participating in section L2 audits from a disclosure point of view, to ensure effective CAPA is applied where required and to ensure timely closure (i.e. within due dates) of CAPAs. Participation (preparation for and fronting question related to validation) in L3 audits as required.
  • Responsible for identifying risks and escalate to the validation lead, where applicable develop risk mitigation plan and monitor the implementation plan.
  • Initiates or, participates in, projects to continually improve process through GSK methodology.
  • Responsible to comply EHS standards & guidelines and Site EHS SOPs.
  • Adhere to Safety & Quality standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect and Zero Waste for continues improvements.

Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • University bachelor’s degree of science, or equivalent experience
  • Minimal of 3 years’ experience in a pharmaceutical environment.
  • Expertise in the field of quality.
  • Good knowledge of cGMP, Validation (Process, cleaning, CSV), Qualification activities (Lab & Production), statistical analysis, GLP, GDP & EHS.
  • Good level of English language (Written & Spoken).
  • Experience of Lab & production processes, equipment and systems.
  • Good documentation ability.
  • Competency level – Competent.
  • Good in Computer skills (Microsoft office).


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.

Closing date:

14/02/2024

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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