Company Job Vacancies in Ankleshwar

Urgent OpeningQuality 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

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.