Job openings for Qa Manager in Ankleshwar

Urgent Opening
Quality Assurance-Head
(API Chemical Company)
Location: Ankleshwar, Gujrat
 Qualifications: Graduate in a science-related field, such as chemistry or pharmacy
 Experience: Minimum 5 years’ experience in pharma from QA Department.
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).
 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