R&D Analyst at Aldelia Limited

Person Specification

• Should have knowledge of ICH quality guidelines and Pharmacopoeia.
• Should be able to set the specifications for active materials, raw materials and packing materials, in-process and finished products.
• Hands on experience in handling all the analytical equipment like UV / HPLC / UPLC / GC / Particle size analysis / ICPMS.
• Hands on experience in Analytical Method Development for non-Pharmacopoeial products.
• 2-5 Years’ Experience

Key Competencies Required:

• Transfer of ADL documents (Spec/STP/Report/Stability) during Technology Transfer to site QC.
• Planning of Validations for Tech-Transfer products, preparation of protocols and reports.
• Handling of incidence, OOS and OOT & Furnishing the CAPA.
• Validation of analytical methods for monitoring the specified quality of Formulations for Assay, Dissolution, Related Substances, Stability & Stability Indicating Methods, Content Uniformity, Forced Degradation, Excipient Compatibility.
• Preparation & review of departmental SOPs, Implementation of SOP & general QMS system through training.
• Should be able to plan and monitor routine analysis of trial batches, validation batches, stability batches and preparation of reports.
• To co-ordinate with Formulation team and QC to prepare the stability protocols for scale-up / Validation / Tech-Transfer batches.
• Compilation protocols, methods, validation reports and stability reports in-line with CTD requirement.
• Good understanding guidelines for matrixing of Analytical method validations for cut off studies.
• Periodic Calibration of instruments & equipment.

go to method of application »

Person Specification

• Should have knowledge of ICH quality guidelines and Pharmacopoeia.
• Should be able to set the specifications for active materials, raw materials and packing materials, in-process and finished products.
• Hands on experience in handling all the analytical equipment like UV / HPLC / UPLC / GC / Particle size analysis / ICPMS.
• Hands on experience in Analytical Method Development for non-Pharmacopoeial products.
• 2-5 Years’ Experience

Key Competencies Required:

• Transfer of ADL documents (Spec/STP/Report/Stability) during Technology Transfer to site QC.
• Planning of Validations for Tech-Transfer products, preparation of protocols and reports.
• Handling of incidence, OOS and OOT & Furnishing the CAPA.
• Validation of analytical methods for monitoring the specified quality of Formulations for Assay, Dissolution, Related Substances, Stability & Stability Indicating Methods, Content Uniformity, Forced Degradation, Excipient Compatibility.
• Preparation & review of departmental SOPs, Implementation of SOP & general QMS system through training.
• Should be able to plan and monitor routine analysis of trial batches, validation batches, stability batches and preparation of reports.
• To co-ordinate with Formulation team and QC to prepare the stability protocols for scale-up / Validation / Tech-Transfer batches.
• Compilation protocols, methods, validation reports and stability reports in-line with CTD requirement.
• Good understanding guidelines for matrixing of Analytical method validations for cut off studies.
• Periodic Calibration of instruments & equipment.