Job Description

Designation : Head QA
Qualifications : Graduate in science-related field, such as chemistry or pharmacy
Experience : More than 15 years in pharma from QA Department.
Salary : Up to 30% hike on current CTC
Location : Ankleshwar -Gujrat

Essential Duties and Responsibilities:

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