Validation Section Head

GSK•Brooklyn Center, MN

8d•Onsite

About The Position

The Validation Section Head will manage and ensure the implementation of Process and Cleaning Validation in compliance with regulatory and QMS. This role involves maintaining the validation status for products through validation lifecycle management and providing support and/or leadership for PLM project(s). The position requires establishing key partnerships across Operations, MSAT, Quality, Supply, Engineering, and Regulatory. The Validation Lead is responsible for ensuring all validation activities are inspection-ready for internal and external audits.

Requirements

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).

Nice To Haves

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.

Responsibilities

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)
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
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