Specialist Equipment Lifecycle

Ras al-Khaimah, United Arab Emirates

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Job Description

Speciaist Required for the Commission & Qualification Activities in Equipment Life cycle Approach.Must haved 3-5 years experience and Having bachelor or Master degree in Engineering/ScienceMain Responsibilities: * Responsible for Equipment Qualification. Executing the Qualification deliverables for initial Qualification i.e Installation Qualification, Operational Qualification & performance Qualification.

Responsible for the Equipment Qualification pharmaceutical Equipment\'s for Oral solid Dosage form (for Examples : Granulators, Compression, FBD, Coaters & Blister packaging etc) Semi-Solids & Oral Liquids (Manufacturing Vessels, Filling lines , labelling ,Packaging Lines) , Sterile area (Autoclave, Tunnel, Vial Filling line, Inspection machine, Lyophiliser etc) .
Preparation and review of validation deliverables like User Requirements Specification (URS), Quality Risk assessment (QRA), GxP assessment, Functional Requirement Specification, DS, FRA, IQ, OQ, PQ, Design traceability Matrix, and summary validation Report etc.
Responsible for the Qualification of Facilities used in pharmaceutical companies.
Responsible for the temperature mapping of Cold Stores & Temperature Controller Chambers.
Responsible for executing validation activities for GxP and computerized systems like Systems in according to the GAMP5 Validation Life Cycle for the Equipments. etc.
Responsible for preparation, review and closure of test incidents/defects and its status reporting.
Perform periodic review or Re-qualification of the Equipments & GxP systems to ensure that they continue to remain validated.
Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.

10. Handling of Validation system related QMS like deviations, change controls and CAPA\'s etc. Responsible for management for validation documents like archiving, retrieving and distribution.

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