Quality Assurance Operation Specialist

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office

Job Description
Thermo Fisher Scientific World Leader in Serving Science is seeking a Quality Assurance Operation Specialist.

SCOPE OF THE POSITION/RESPONSIBILITIES:
Reporting to the QOPS Team Leader and QOPS Supervisor, the specialist supports the Qualified Person in the assessment of produced batches and the working environment by verifying documentation and necessary information. Under the guidance and coordination of the Team Leader, they conduct investigations into GMP-relevant issues and deviations, and handle customer complaints in accordance with standards, company procedures, and current regulations (laws, GMP standards, FDA, etc.). They act as the point of contact for customers regarding Quality Assurance aspects related to commercial productions.

SPECIFIC TASKS/PRIMARY ACTIVITIES:

1. Preparation for Release of Commercial Batches and Compliance Judgment:
   Under the guidance of the Team Leader, ensures compliance with batch specifications through the completion of release Check Lists in accordance with SOPs, current regulations (laws, GMP standards, FDA, etc.), and company quality standards.
2. Deviation Management and Investigation Report:
   Conducts investigations into deviations from the production process to identify the Root Cause through document verification and close collaboration with support functions (production, maintenance, QC, Opex) in compliance with SOPs, current regulations (laws, GMP standards, FDA, etc.), and company quality standards.
3. Complaint Management:
   Investigates customer complaints by understanding causes and identifying appropriate corrective or preventive actions, collaborating with support structures (production, maintenance, QC) to maximize customer satisfaction with the received service, in compliance with SOPs, current regulations (laws, GMP standards, CFR 21, FDA, etc.), and specific agreements signed with customers.
4. Audit Support:
   Assists the Team Leader in the preparation and management of customer audits and regulatory bodies.
5. Quality:
   Operates in accordance with company quality standards by applying procedures relevant to the areas of competence, in compliance with company quality policies and procedures.

REQUIREMENTS AND QUALIFICATIONS:

ESSENTIAL
Education/Diploma/Training Courses:
* Degree in CTF, Pharmacy, Chemistry, Biology or similar scientific disciplines.
Technical and Computer Skills:
* Production and control of pharmaceutical products.
* GMP/FDA standards.
* Good knowledge of written and spoken English.
* Ability to work in a team and excellent interpersonal skills.