
QA - Head
20 hours ago
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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