Analytical Development and GMP Specialist
1 settimana fa
Job Summary
The PDS Analytical Development & GMP Scientist is a crucial link between Analysts and Team Leader/Supervisor, working closely with clients and handling laboratory activities.
Key Responsibilities:
- Ensures both the execution and constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts in problem-solving for analytical activities relating to API / DS and finished products (Release and Stability)
- Draws up analytical specifications, study protocols and reports, analytical methods and SOPs in compliance with current regulations (current EU GMP, US GMP) and company quality standards
- Coordinates customer management with the aim of maintaining a high level of customer satisfaction and completing the required activities on schedule
- Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise
- Identifies the requirements for analytical technology transfer from customers, then ensuring the accurate and effective transfer to the laboratories
- Handles laboratory investigations (Out of Specification and Deviation Reports)
Requirements
- Education
- Degree in CTF, Chemistry, Biology or other similar fields
- Diploma Chemical/Laboratory technician certificate
- Experience
- Multi-year experience in Quality Control in pharmaceutical industries
- Knowledge, Skills, Abilities
- Knowledge of the main techniques of chemical-physical and biochemical analysis and validation of analytical methods
- Knowledge of GMP and national/international regulations
- Good problem-solving abilities
- Proficiency in Microsoft Office suite and both analytical and statistical software (Empower, MiniTab, Sample Manager)
- Prepared to work with conflicting priorities and under time constraints
About Us
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
As an Equal Opportunity Employer, we welcome applications from diverse candidates and are committed to a fair and inclusive hiring process.
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