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.
#J-18808-Ljbffr