Job openings for Quality Manager in Mumbai Navi Mumbai

Designation : QA Manager
Location : Mumbai
Qualifications : Degree in a science-related field, chemistry or pharmacy
Experience : 3+ years in R&D Pharmaceutical Industry from QA Department
Responsibility :
* Review of Manufacturing Processes.
* 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.
* QA person collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
* The QA person conducts regular internal audits of the manufacturing facility at R&D to ensure that the facility meets the required quality standards. Also handles the external audit cand its compliance.
* QA person is responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements
* The QA person is responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.
* The QA person is responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA)
* QA person is 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 of product at Pilot plant manufacturing site.
* Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
Contact Person- Deepak - 7757087059
ID- deepak.vijayamgmt@gmail.com