GSK
Pharmaceutical
ValidationSectionHead
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Validation Section Head at GSK. Skills: Process Validation, Cleaning Validation, QMS principle. Manage implementation of Process and Cleaning Validation. Ensure compliance with regulatory and QMS”
What You'll Achieve.
Ensure successful inspection; Meet GSK and Industry expectations; Meet regulatory requirements
Industry & Context.
Problem solving; Root cause analysis
What They're Looking For.
Must Have
Bachelor's Degree in pharmaceutical sciences or science related field, 2 - 4 years of experience in similar position (Validation), Good knowledge of GMP within a Pharmaceutical Environment, Good knowledge of Process Validation, Good knowledge of Cleaning Validation, Good knowledge on at least one dosage from OSD, Liquids & Semisolids, Effective communication skills, Ability to communicate and influence stakeholders, Proven track record of problem solving, Knowledge and application of QMS principle, Fluent in English and Arabic (both written and spoken)
Nice to Have
Practical experience of use of SAP system, Practical experience of statistical analysis, Excellent verbal and written communication skills, Demonstrated ability to work in a matrix environment, Well-developed influencing and negotiation skills, Experience in internal and regulatory audits
What You'll Do.
Manage implementation of Process and Cleaning Validation
Ensure compliance with regulatory and QMS
Maintain Validation status for products
Provide support and/or leadership for PLM project(s)
Establish key partnerships across Operations
Maintain all validation activities in inspection ready state
Issue site Process validation master plan
Document and sign the PPQ rationale and protocol
Develop sampling and testing strategy
Execute PPQ across all operational shifts
Withdraw and send samples to lab
Document and sign PPQ report
Provide statistical assessment for variability
Create cleaning validation master plans
Define the cleaning program
Calculate maximum allowable carry over (MACO) limit
Perform routine monitoring
Perform periodic review for validated cleaning processes
Create cleaning risk assessments
Define controls to mitigate identified risk(s)
Determine need for dedication
Issue impact assessments in case of product/machine changes
Determine worse case marker
Create the cleaning validation protocol
Execute 3 cleaning validation runs
Execute 1 verification run
Verify the cleaning CPPs
Create cleaning validation reports
Review the analytical method
Maintain the cleaning validation status
Issue annually cleaning validation review
Issue maintenance plans
Owner of cleaning validation tracker
Present site in Cleaning validation CoP
Lead technical deployment of cleaning global strategy
Set-up cross-functional teams as validation working parties
Determine validation scope for technical and engineering projects
Ensure appropriate level of validation activities is built
Execute validation activities to meet regulatory requirements
System Owner (Local SOP updates)
System Owner (QMS gap analysis)
System Owner (relevant deviations/CCRs/CAPAs)
System Owner (L2/3/4 audit fronting)
Present & justify validation scope and documents to
Lead continuous improvement initiatives associated to Validation/Qualification
Align initiatives with team and site objectives
Ensure team and key customers are kept informed
QMS and GPS are supported
How You'll Work.
Team & Collaboration
Cross-functional teams; Key partnerships
Communication Scope
Effective communication; Influence stakeholders; Verbal communication; Written communication
Process & Methodology
PLM project(s)
Full Job Description
**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 verif
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