CQA Executive

Troikaa Pharmaceuticals; Dehradun; On-site; INR 450,000 - 550,000; Full time

Job summary

Troikaa Pharmaceuticals requires a QA auditor to conduct internal GMP audits across areas at the site in Dehradun. The role involves following the audit schedule, ensuring training, validation and quality functions align with documented procedures and regulatory expectations.

Responsibilities include safeguarding CGMP/GLP compliance in QC, maintaining facility checklists, collecting data for CAPA, monitoring water and environmental trends, and reviewing investigations of Deviation, Incident, OOS

Responsibilities

• Carry out internal audits of GMP areas at site
• Follow audit schedule and perform audits per SOP
• Ensure training, validation and quality function compliance with documents
• Ensure systems and procedures comply with current regulatory expectations
• Ensure compliance of analytical data (analyst qualification, finished product data)
• Ensure cGMP and GLP compliance in quality control department
• Maintain building maintenance per respective checklists
• Collect and evaluate data to identify areas of improvement; monitor CAPA effectiveness
• Review trend data of water system, environment monitoring, change control, deviation, CAPA, etc.
• Review investigations of Deviation, Incident, OOS and OOT

Job description

1. 1.To carry out the internal audit of different GMP areas at site
2. 2.To follow the internal audit schedule and perform the audit as per SOP.
3. 3.To ensure compliance of training, validation and quality function pertaining to adherence with document.
4. 4.system and procedure in accordance with the current regulatory expectations.
5. 5.To ensure the compliance of analytical data such as Analyst qualification, Finished product analysis data
6. , stability data, Analytical method validation protocols, report, Calibration, OOS and Incidence
7. 6.Ensure compliance of JR with their functional across the plant.
8. 7.To ensure cGMP and GLP compliance in quality control department.
9. 8.To ensure wII keeping of building maintenance as per respective checklist.
10. 9.Collect, evaluate data and identify the area of improvement, recommend and monitor effectiveness of CAPA
11. 10.Ensure compliance of trend data of water system, environment monitoring system, change control,deviation, Incident, out of specification, CAPA, etc.
12. 11.To review investigation of Deviation, Incident, OOS and OOT.