PDS AD&GMP Regulatory Documentation Specialist

Work Schedule

Environmental Conditions

Job Description

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 AD&GMP Regulatory Documentation 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 Technical Writer&Compliance Supervisor you will be responsible for the assigned projects and for ensuring compliance with regulatory specifications related to the QC PDS Laboratory.

Your role will be critical in supporting the successful progression of projects within the PDS.

Job Responsibilities

• Oversee assigned projects and ensure compliance with regulatory specifications related to the QC PDS Laboratory to support project progression within the PDS.
• Collaborate with internal departments (Production QA Regulatory Logistics TT/Business) and external supplier (Clients External Laboratories) to implement analytical specifications aligned with company quality standards.
• Manage regulatory specifications for APIs Materials Excipients and Drug Products (release and stability tests).
• Work with clients laboratory and the Regulatory Department to develop specifications for PDS projects in compliance with ICH guidelines and pharmacopoeia standards.
• Provide regulatory consulting and strategic advice to internal and external clients on regulatory and product development specifications.
• Develop project-specific strategies and offer technical expertise in regulatory matters. Serve as the main point of contact for key clients including participation in regulatory authority meetings and public relations activities.
• Ensure compliance with cGMP regulations and quality standards contributing to deviation management CAPAs and change controls for all phases of PDS projects.
• Draft review and update procedures in the area of competence ensuring adherence to regulations laws and GMP standards.

Education and Experience

• Bachelors degree in chemical pharmaceuticals biology chemistry biotechnology or a related field (Masters degree preferred) or equivalent experience.
• Prior experience in analytical laboratories or pharmaceutical technology laboratories.

Technical and IT Knowledge

• Proficiency in GMP standards for Quality Control laboratories.
• Familiarity with laboratory concepts data management and evaluation systems.
• Familiarity with stability and routine tests for APIs and finished products.

Languages

• Fluency in English (written and spoken).

Personality Traits

• Flexibility and adaptability.
• Strong organizational and planning skills.
• Excellent communication skills (listening oral and written).
• Team-oriented mindset and ability to collaborate effectively.