R&D Analyst at Aldelia Limited
Posted on: 21 May, 2019
Deadline: 22 May, 2019
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Aldelia Group - Our client, a Pharmaceutical Company is looking to hire the services of:
- 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.
Method of Application
Applicants should send their Applications and CV to: firstname.lastname@example.org
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