Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job 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.