Urgent Hiring || QA Head || Ankleshwar, G I D C , Gujarat ||
Designation: QA - Head
Qualifications: Graduate in science-related field, such as chemistry or pharmacy
Experience: 15-16 years’ experience in pharma from QA Department.
Salary: Upto 16 LPA
Location: Ankleshwar, G I D C , 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 valuable 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