Qa Validation Supervisor
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job DescriptionJob Responsibilities: Lead a team at Thermo Fisher Scientific Inc. as a QA Validation Supervisor.
Ensure flawless quality and compliance. Review the Validation Master Plans for Process and Cleaning, following current regulations (GMP, FDA, etc. )
and company quality standards. Validation Documentation: Guarantee the accuracy and quality of validation and revalidation documentation for equipment, production, and cleaning processes through meticulous review and coordination. Validation Reports: Coordinate the correctness and quality of Validation Reports, ensuring compliance with the Validation Master Plan and SOPs. Audit Support: Assist in preparing for and participating in external audits by providing necessary information and documentation. Change Control: Coordinate change control activities related to the introduction of new products, ensuring alignment with company procedures. Quality Assurance: Maintain outstanding quality standards by verifying the application of relevant procedures and policies. SOP Updates: Ensure continuous updates of SOPs and related documentation, adhering to GMP requirements. Team Management: Lead and develop your team by setting clear objectives, recognizing achievements, and addressing training needs. Job Requirements: Essential Qualifications:Education: Degree in Pharmacy, Biological Sciences, Chemistry, or Chemical Engineering.
Equivalent experience in Pharmacy, Biological Sciences, Chemistry, or Chemical Engineering is also acceptable. Technical Skills: Familiarity with pharmaceutical processes, Microsoft Word and Excel, basic analytical methods, statistical analysis software, and pharmaceutical legislation. Experience: Proven experience in equipment, process, and cleaning validation, aseptic production, and quality assurance. Language Skills: Excellent written and spoken English. Personal Traits: Strong interpersonal skills, attention to detail, organizational abilities, and a sense of dedication to quality. Desirable Qualifications: In-depth knowledge of pharmaceutical legislation. Advanced analytical techniques (chemical and microbiological). Experience in personnel management. #J-18808-Ljbffr
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