QA Head

• Ø Knowledge of all regulated Guideline & Pharmacopoeia.
• Ø Preparation & implementation of SOPs related to the concerned department & Justification of Specification.
• Ø Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing.
• Ø collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
• Ø The conducts regular internal audits of the manufacturing facility to ensure that the facility meets the required quality standards.
• Ø handles the Regulatory and Customer audit and its compliance.
• Ø Responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements
• Ø Responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.
• Ø Responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA).
• Ø Responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.
• Ø Handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.
• Ø Preparation & review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.
• Ø Implementation & verification, in-process checks, online entries in BPR
• Ø Review of Manufacturing Processes.
• Ø Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
• Ø Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure
• Ø Preparation & review of Quality Risk Assessment.
• Ø Preparation & review of process validation, cleaning validation, equipment qualification
• Ø To prepare/review the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout and other documents related to QA

• API Pharma Candidate must have perfection in English communication. Knowledge of all regulated Guideline & Pharmacopoeia.
• Must have Knowledge all documentation of QA

Job Type: Full-time

Pay: From ₹180,000.00 per month

Work Location: In person

Speak with the employer
+91 9522225540