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Alpina HR is looking for a Werum Project Quality Manager / Validation Expert (m/f)
The PQM / validation lead, will enable the project team in fulfilling the requirements as per customer project lifecycle methodology (ICE), templates and documentation deliverables. While working closely with project team and will be responsible for authoring and reviewing of key project deliverables. The PQM will support will be through the lifecycle activities of a validated system.
PQM must create/ prepare, review and approve project and system life cycle documentation where applicable and conduct tollgate reviews as per the project schedule.
Will be responsible for end to end validation & related documents for PAS-X MES application
Authoring of the site related quality and validation documents like MES Validation Plan, Traceability Matrix, Reports for Infrastructure Acceptance Q/P, site Test Overview List, IQ and Functional Test Summary reports, Site User Acceptance Test Summary Report, Validation Report and maintain the Project Change Request & Deviation Logs
His responsibility also includes Review and Approval of Documents like MES In-Project Training Plan, Tollgate Review for the project phases, Hardware and Design Specification, Architecture Handbook, Configuration Specification for IT and Business, Site IQ Test Specification, Functional Test Specifications, Site Cut-over Plan & Handover checklist (from PMX to PAS-X), Site Hand-over Checklist and Site Acceptance Report
The Quality Manager has to act as Test Manager during the test phases and should enable co-ordinate the test execution between validation lead and BA, should report the testing status periodically.
Updating the IQ/OQ/UAT documents as required
Create all necessary protocols/scripts for the execution of identified tests.
Execution & support of UAT as per plan.
Generating the summary test reports and assists related communication with site SPOC.
Supports risk assessment and system lifecycle processes such as change control and document management.
Assists in resolving and documenting deviations in technical and project-related issues.
Validation experience in a FDA regulated industry.
Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 820) used in GxP environment and related FDA guidelines, regulations.
Authoring and Review of validation deliverables including, but not limited to Validation Plan, URS, FRS, IQ, OQ, PQ, Qualification Reports, Summary Reports.
Proficient in validation process methodologies, risk management, etc.
Minimum of 5-7 years of relevant project management experience mandatory.
Experience in testing and validation projects for Manufacturing Execution Systems (MES) deployment projects (e.g. Werum PAS-X)
Must understand the pharmaceutical processes and systems scope, especially with batch manufacturing
Knowledgeable in FDA validation requirements preferred
Trained on Werum PAS-X preferred
If you are interested in this project, please send us your CV as a Word file and a phone number where we can reach you at firstname.lastname@example.org