Quality Assurance Manager

Urgent Hiring || QA Head || Ankleshwar -Gujarat Designation : QA - Head Experience : Minimum 15 to 19 years’ experience in pharma from QA Department. Salary : upto 15 lpa (Depend on the interview) Location: Ankleshwar -Gujarat 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 Show more Show less