Senior Executive, Analytical R&D Documentation | Injectable

Essential Functions:

• Preparation of SOPs, Specifications, and method of analysis (Raw material, In-Process and Finished product)
• Review of DMF to prepare Analytical method and specification
• Initiate Change Control and Deviation.
• Good understanding for Impurity profiling
• Well versed with regulatory agency's current requirement.
• Well versed with ICH quality guidelines
• Good knowledge for Pharmacopoeia
• Good communication especially writing skills for preparing quality documents and coordination with Cross functional teams.

Skills:

• Quality based Regulatory Submission Documentation - Advanced
• Document Review & Evaluation as quality and regulatory standard - Intermediate
• CAPA (Corrective and Preventive Actions) Documentation - Advanced
• Cross-Departmental Coordination - Advanced
• Change Control Documentation - Advanced
• Good Documentation Practices (GDP) - Intermediate
• Laboratory Information Management System (LIMS) - Advanced
• open to feedback and coaching - Advanced

Education:

• Bachelor’s Degree (BA/BS) B.Sc. - Required
• Master Degree (MS/MA) M.Sc. - Preferred
• Bachelor’s Degree (BA/BS) B. Pharm - Preferred
Master Degree (MS/MA) M.Pharm – Preferred

Experience:

• 4 years or more in 4-7 Yrs