Validation Section Head GlaxoSmithKline

Scope:

Manage and ensure the implementation of Process and Cleaning Validation are carried out in compliance with regulatory and QMS. Maintain the Validation status for products through validation lifecycle management.

Key Responsibilities:
In this role, you will be responsible for the following:

• Validation Lead is expected to provide support and/or leadership and establish key partnerships across Operations, MSAT, Quality, Supply, Engineering and Regulatory for the PLM project(s) for which he/she is accountable on

• Maintain all validation activities in an inspection ready state for any internal and external audits to ensure successful inspection

For process Qualification; He/She is accountable on:

• Issue site Process validation master plan (at least annually)

• Document and sign the PPQ rationale and protocol with developing sampling and testing strategy (as per site VMP, changes & deviations)

• Execute PPQ across all operational shifts as needed, including samples withdrawal and sending to lab

• Document and sign PPQ report with statistical assessment for variability within batch and between batches (on-going as per site VMP, changes & deviations)

For Cleaning Validation; ; He/She is accountable on:

• Create cleaning validation master plans and rationales to define the cleaning program , including calculation of maximum allowable carry over (MACO) limit, considering campaign length, DHT and CHT

• Execute CV runs,routine monitoring and periodic review for validated cleaning processes across all operational shifts, as needed

• Create cleaning risk assessments/hard to clean assessment for each machine and define controls to mitigate any identified risk(s) and the need for dedication if required together with issuing impact assessments in case of product/machine changes

• Determine worse case marker based on worse case marker selection tool

• Create the cleaning validation protocol, execute the 3 cleaning validation runs and/or 1 verification run and verify the cleaning CPPs

• Create cleaning validation reports

• Review of the analytical method

• Maintain the cleaning validation status by issuing of annually cleaning validation review and maintenance plans

• Owner of cleaning validation tracker

• Present site in Cleaning validation CoP (monthly) and lead the technical deployment of the cleaning global strategy to the Cairo Site, to meet GSK and Industry expectations

• Member of month to date plan meeting for planning execution dates on cleaning validation runs, BHT and PPQ

• To set-up and lead cross-functional teams as validation working parties to determine the validation scope for technical and engineering projects, ensuring the appropriate level of validation activities is built into project plans and executed to meet regulatory requirements

• System Owner (Local SOP updates, QMS gap analysis, relevant deviations/CCRs/CAPAs, L2/3/4 audit fronting , L1)

• Present & justify validation scope and documents to both internal and external auditors

• lead and participate in continuous improvement initiatives associated to Validation/Qualification activities in alignment with team and site objectives

• Ensure that both team and key customers are kept informed of changes to validation requirements

• Ensure that EHS, QMS and GPS are supported

Why you?

Basic Qualifications:

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

• Bachelor's Degree in pharmaceutical sciences or science related field.

• From 2 - 4 years of experience in similar position (Validation);

• Good knowledge of GMP within a Pharmaceutical Environment.

• Good knowledge of on the following: Process Validation (including continuous verification) and Cleaning Validation.

• Good knowledge on at least one dosage from OSD, Liquids & Semisolids.

• Effective communication skills and ability to communicate and influence stakeholders.

• Proven track record of problem solving.

• Knowledge and application of QMS principle.

• Must be fluent in English and Arabic (both written and spoken).

Preferred Qualifications:

• Practical experience of use of SAP system and statistical analysis.

• Excellent verbal and written communication skills.

• Demonstrated ability to work in a matrix environment with well-developed influencing and negotiation skills.

• Experience in internal and regulatory audits.

Application Closure Date: 14 June 2026

Please submit your CV in English.