Validation Coordinator

**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, im