Quality Manager - Pharma (Male)

Vijaya Management Services

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 -

ID-

• Experience3 - 9 Years
• No. of Openings2
• EducationDiploma, Professional Degree, B.Sc, B.E, B.Tech, M.Sc
• RoleQuality Manager
• Industry TypeChemicals / PetroChemical / Plastic / Rubber / Glass / Paints
• GenderMale
• Job CountryIndia
• Job TypeWork from Office