QA Specialist
1 day ago
KEY DUTIES AND RESPONSIBILITES: Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines. Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility. Candidate must have knowledge and experience of qualification/validation principles and their practical application. Preparation and review of process and cleaning validation protocols and reports. Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems,and processes in validated state. Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes. Write, review, and revise validation SOPs in compliance with regulatory guidelines. QA oversight and/or review during the validation process. Manage incidents and deviations related to validation & qualification. Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation. Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies. Cross train and develop expertise in other areas of validation. Must be able to interact and lead effectively in a team-based environment. Familiarity with regulatory/compliance environment. EDUCATION & EXPERIENCE Degree a scientific discipline or equivalent. Experience in a regulated industry preferred. A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environment. Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer. TO APPLY Candidates are encouraged to apply this position via email to with the following information in the resume. Work experiences and job responsibilities Current and Expected salary Reason for leaving Date of availability Education background We regret that only shortlisted candidates will be contacted. #J-18808-Ljbffr
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QA Specialist
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QA Specialist
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QA Specialist
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Singapore World of Tanks Full timeJoin to apply for the Localization QA Specialist, Simplified Chinese role at World of Tanks . Job Overview As a dedicated Localization QA Specialist, you will participate in the localization of game client and content for Wargaming.net. Reports to Head of Localization & QA/Customer Support, APAC. What will you do?Test game localization; assess product...
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