Pds Technical Writer&gmp Compliance Specialist

3 settimane fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

At Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer. With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values performance, quality, and innovation. Join our team and be a part of a successful, growing global organization where you will be encouraged to perform at your best and make significant contributions to the world.

As a PDS Technical Writer&GMP Compliance Specialist, you will have a unique opportunity to be part of the PDS Analytical Development&GMP Department in our newly built Pharmaceutical Department. Reporting to the PDS AD&GMP Supervisor, you will be responsible for the documentation related to QC PDS Laboratory, ensuring the successful continuation of projects within the PDS. Equivalent experience will also be considered for educational requirements like PDS.

Job Responsibilities
- Collaborate with all functions within the company to implement analytical requirements and adhere to company quality standards.
- Prepare analytical documentation for APIs, Excipients, and DP (release and stability tests), including the preparation of analytical methods and their upload on computerized systems.
- Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA, and QO to issue the correct documents for PDS projects, ensuring compliance with ICH and Pharmacopoeia standards.
- Provide compliance consulting and strategic advice to internal and external clients, determining the most appropriate approach for compliant documentation.
- Contribute to project-specific strategies, providing technical expertise in QC Documentation and overseeing collaboration for key client projects.
- Ensure quality performance for key/managed projects by working collaboratively with the QC Documentation Team.
- Support the QC PDS Documentation Team in handling Deviations, CAPAs, and Change Controls for all phases of PDS Projects.
- Continuously improve analytical skills and maintain compliance with cGMP regulations to ensure full Quality compliance.
- Support laboratory investigations, OOS (Out of Specification), OOT (Out of Trend) evaluations, and contribute to defining CAPAs.
- Contribute to updating and reviewing procedures related to the area of competence, ensuring compliance with current regulations, laws, and GMP standards.
- Collaborate with the team to plan future customer activities and solicit projects aligned with company goals and objectives.

Job Requirements
- Bachelor's degree in chemical engineering, chemistry, or equivalent degree with relevant experience.
- Strong technical and IT knowledge, particularly in GMP standards applied to Quality Control laboratories and stability studies.
- Proficiency in laboratory concepts and computer programs.
- Familiarity with data management and evaluation systems.
- Previous experience in analysis laboratories at universities or pharma companies.
- Excellent communication skills, both written and verbal.
- Strong organizational and planning skills.
- Flexibility, adaptability, and ability to work in a team.

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