Hiring for QA Head - Ankleshwar (API Pharma)

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