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-

• Experience

  3 - 9 Years

• No. of Openings

  2

• Education

  B.E, B.Sc, B.Tech, Diploma, M.Sc, Professional Degree

• Role

  Quality Manager

• Industry Type

  Chemicals / PetroChemical / Plastic / Rubber / Glass / Paints

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office