Quality Assurance Specialist
4 settimane fa
**Elevate Your Career with Thermo Fisher Scientific**
We are seeking a highly skilled Investigation & Client Quality Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality unit, you will play a vital role in ensuring the highest standards of quality and compliance in our operations.
**Key Responsibilities:**
- Collaborate with colleagues to coordinate technical and management meetings with customers, ensuring seamless communication and resolution of quality-related issues.
- Participate in customer visits and quality inspections (Audits) to verify compliance with regulatory requirements and technical agreements.
- Generate reports on quality events, providing actionable insights to drive process improvements and risk mitigation.
- Contribute to the achievement of quality objectives, including RFT, Deviation Rate, Past due, and On-time closure objectives.
- Provide technical support to customers via TLC and email, responding promptly to quality-related inquiries.
- Participate in the drafting of FMEAs, ensuring the highest standards of quality and risk assessment.
- Manage the drafting, archiving, and distribution of controlled company documentation, ensuring compliance with regulatory requirements.
- Train personnel involved in PDS/DPS quality activities, ensuring a high level of quality awareness and compliance.
- In collaboration with Compliance colleagues, review and draft Quality System SOPs, ensuring alignment with regulatory requirements and technical agreements.
**Requirements:**
- Degree in CTF, Biotechnology, Pharmacy, Chemical Engineering, Management Engineering, or a related field.
- At least 6 months to 1 year of experience in similar roles in the pharmaceutical sector.
- Proficiency in English, both written and oral.
- Post-degree courses in QA are considered a plus.
- GMP knowledge and main IT software proficiency are essential.
**What We Offer:**
- An initial fixed-term contract for 12 months.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
**Join Thermo Fisher Scientific and contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer.**
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