QA/Quality Assurance Head (API Chemical Company) Ankleshwar

Double HR Consultancy

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

• Experience

  5 - 8 Years

• No. of Openings

  6

• Education

  B.Pharma, B.Sc, M.Pharma, M.Sc

• Role

  Quality Assurance Head

• Industry Type

  Chemicals / PetroChemical / Plastic / Rubber / Glass / Paints

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office