Good knowledge & experience in applying the US FDA CFR21, EU EDQM (Directorate for Quality of Medicines & health care) and the ICH regulations & standards.
Experience in follow up & implementation of the cGMP, GDP, GLP and GEP.
Experience in Preparation of quality system documents (QSDs) like SOPs, Logbooks, Forms etc.
Experience in Maintaining the QSDs as per good documentation practices.
Experience in Documents Control, Issuance, Retrieval, Reviews and Archival of all QSDs like, Batch Manufacturing Records (BMR), Analytical Reports, forms, logbooks, protocols and reports of different department.
Experience in the in process control laboratory.
Experience in follow up & implementation of the internal auditing and self assessment.
Experience in performing line clearance to ensure Mix up prevention
Experience in follow up preventive maintenance & calibration programs implementation.
B.Sc. in Pharmacy, Chemical Engineering, or Chemistry from a reputable university / Institute
Minimum 5 years in pharmaceutical industry
Between 25 - 35 years
• API knowledge
• Communication Skills
• Computer Skills
• English Reading/Writing/Speaking