Dr. Rajathees Rajaratnam

EU-Chargenfreigabe; Prüfung und Freigabe von Ausgangsstoffen, Bulk- und Fertigarzneimittel; Pflege und Weiterentwicklung des Qualitätsmanagementsystems; Sicherstellung der GxP-Compliance; Einhaltung von (inter)nationalen GMP-Richtlinien; Erstellung und Verhandeln Qualitätsverträgen; Management von Abweichungen, CAPA-Prozessen, Änderungskontrollen, Risikobewertungen und regulatorischen Anforderungen; Organisation und Durchführung von Schulungen; Auditmanagement; Selbstinspektionen; Quality Management Review.

- Certification of bioanalytical assays - Assurance of the trained status of the analysts - Surveillance of the qualification and maintenance of equipment and facilities - Assurance of the validated status of the applied methods - Consulting and assistance in the compilation of CMC documents for MAH´s - Risk Assessments for variations of approved market authorizations - Consulting in terms of dossier requests by the regulating authorities - Assurance of the regulatory compliance of performed services

- Certification of Bioanalytical Assays - Approval and Assurance of Specifications, Sampling Plans and Testing Monographs - Assurance of the Application of all Relevant Analytical Tests - Surveillance of the Qualification and Maintenance of Equipment and Facilities - Assurance of the Validated Status of the Applied Methods - Assurance of the Initial and Continuous Training of Analysts

- Release of Starting Materials, Packaging Materials, Bulk and Finished Product - Approval and Assurance of Specifications, Sampling Plans and Testing Monographs - Assurance of the Application of all Relevant Analytical Tests - Approval and Surveillance of Contract Laboratories - Surveillance of the Qualification and Maintenance of Equipment and Facilities - Assurance of the Validated Status of the Applied Methods - Assurance of the Initial and Continuous Training of Analysts

- Release of Starting Materials, Packaging Materials and Bulk - Approval and Assurance of Specifications, Sampling Plans and Testing Monographs - Assurance of the Application of all Relevant Analytical Tests - Approval and Surveillance of Contract Laboratories - Surveillance of the Qualification and Maintenance of Equipment and Facilities - Assurance of the Validated Status of the Applied Methods - Assurance of the Initial and Continuous Training of Analysts

- Method Validations - Root-Cause Analysis of Deviations - OOE, OOT & OOS – Management - Risk Assessments - Qualification of Coworkers, Equipment, Suppliers, and Service Provider - Evaluation of Batch-Record-Reviews - Complaint-Management - APR´s and PQR´s - Evaluation of Third-Party Audit Reports - Consistency Checks of Dossiers, Production Records, and Shipping Documents - Assistance in Pharmacovigilance - Assistance in Shipping Release - SOP-Management

- Assurance of the Compliance according to the EU GMP-Guidelines - Management of SOP’s and Master Batch Records - Supplier Qualification - Equipment Qualification and Process Validation - Risk Management and Change Control - Review and Verification of Technical Agreements - Management of First, Second, and Third Party Audits - Correspondence with Stakeholder, Supplier, and Government Agency - Implementation of the Serialization Requirements and the Tamper Proof Evidence

responsibility for lectures and practical courses in organic chemistry for chemistry and pharmacy students on bachelor, master and 1st state examination level and supervision during research projects; assurance of saftey requirements in the isotope laboratory.

"Pharmacologic Characterization of Amino Acids involved in the Binding of hmGlu2-specific Positive Allosteric Modulators." Investigation of the pharmacologic properties of drug candidates towards hmGlu2 and hmGlu3. The work covered the culturing of adherent cell suspension and transformed bacteria, plasmid purification, transfection of mammalian cells, generation and purification of receptor membranes as well as competitive studies using radio-labeled ligands against wild type and mutated receptors.

Development of biomarkers for Alzheimer's disease. Qualitative and Quantitative determination of cytokines via the Bio-Plex Multiplex System. Statistical evaluation of data and pattern recognition as prediction criteria to cluster healthy subjects from diseased.

Qualitative and quantitative determination of drugs and their metabolites in human samples like serum, urine and liquor. The working experience covered the entire practical preparation of the samples, the analysis and the evaluation of the received data. Applied methods and instruments included HPLC, UV and LC-MSMS.

GMP-Intensive Training: Essentials of GMP in Germany Europe and USA; GLP-Intensive Training: Method Validation and Equipment Qualification; Quality Systems GMP and GLP - Guidelines of Good Practice; Method Validation in Analytical Chemistry under QS Requirements

Topic: Design and Synthesis of Enantiopure Organometallic Kinase Inhibitors as Potential Chemotherapeutics. Competences: Organometallic Chemistry and Synthesis; Analytical Method Development and Data Evaluation; Isotope Labelled Competition Assay Development and Pharmacologic Data Evaluation

Marburg, Program of Study: „Medicinal Chemistry“, Fast-Track, Top 5% Competences: Advanced Organic Chemistry; Natural Product and Drug Synthesis; Drug Design; Pharmaceutical Chemistry; Pharmaceutical Analytics

Mannheim, Program of Study: “Biological Chemistry”, Diploma (1.7) Competences: Biochemistry; Microbiology and Immunology; Genetic Engineering; Cell Biology; Bioanalytics