QA - Head

20 hours ago


Ahmedabad, Gujarat, India Orbitouch Outsourcing Private Limited Full time ₹ 1,50,000 per year

Designation : QA - Head

Experience : Minimum 15 to 19 years' experience in pharma from QA Department.

Salary : 15 lpa

Location: Ankleshwar -Gujrat

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 good 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

Job Types: Full-time, Permanent

Pay: ₹12, ₹15,000.00 per year

Schedule:

  • Day shift

Application Question(s):

  • Are you qualified with Diploma/Degree in B.sc, M.sc, pharma or relevant field?
  • are you most comfortable with location Gujrat?
  • what is your current annual salary / ctc?
  • what is your expected annual salary / ctc?
  • How many years of Proven experience in Qa?
  • How would you rate yourself on a scale of 1 to 10?" between your experience /skills & as required experience in job descriptions?
  • what is your notice period? (in days)

Work Location: In person



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