Summary
Education: UG - B.Sc - Chemistry PG - M.Sc - Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production, Maintenance, Quality
Desired Candidate Profile
Minimum M.Sc. (Post Graduate in Science Stream)
Minimum Experience of 4 to 5 Years in a good Pharma Company.
age between 28 to 35 Years
Excellent spoken and written communication skills in English language
Well versed with cGMP requirements & Quality Assurance activities
Exposure to USFDA, TGA & MHRA Audits
Well versed with MS office (latest versions)
Practical experience of preparation of QA documents (SOPs, Qualification, Validation, Stability Protocols & Reports, Master Manufacturing Records, Product Reviews, )
Independent working with minimal supervision
Knowledge of ISO 9001:2008 and SAP will be an added advantage
Job Description
Preparation of QA and ISO 9001:2008 documents complying USFDA requirements
Prepare, maintain, control and issue quality system documents while adequately maintaining the Documents Management System
Taking rounds in and reporting observations
Conducting and imparting cGMP training to employees
Control of Documents
Archiving of documents
Conducting cGMP & ISO 9001:2008 Self Inspections
Conducting Vendor Audits, Preparing Vendor Audit reports
Coordinating with various departments for Change Control, Validation, Stability Studies, Investigation of Deviations / Customer Complaints
Issuing of documents to various departments
Keywords: Quality Assurance, Pharmaceuticals
Company Profile
Renowned MNC
Pharma Company
Contact Details
Company Name: Renowned MNC Pharma Company
Executive Name: Pravin Gangurde
