Role & responsibilities
To ensure that all the activities carried out as per approved standard operating procedures and regulatory norms.
To review the other department SOPs and ensuring the adherence to cGMP requirements
To review Master Batch Manufacturing Records (MFRs, BMRs, ECRs & BPRs)
To review the executed Batch Manufacturing Records, batch packing records & Equipment cleaning records.
To participate in the investigations like OOS,OOT investigations, Deviation investigations etc.
To prepare P/roduct Quality Review (PQR), Continuous process verification.
To participate in the process validation & cleaning validation activities.
To initiate and review the Change Controls.
To review and monitor the corrective and preventive actions.
To maintain the documents and relevant logbooks e.g. Deviation, Change control, OOS, OOT,CAPA etc.
To monitor effectiveness of CAPA and change controls.
Distribution and issuance of all GMP documents.




To archive the master copies of production relevant master documents and master SOPs of all departments.
To issue the BMR, BPR ,ECR & Analytical worksheets.
To review analytical reports, Specifications, COA etc.
Participate in all qualification and validation related activities.
Responsible for handling qualification/requalification related activities.
Responsible for handling Calibration and approval of certificates
Responsible for dispatch activity
To give line clearance.
Support the customer and authority inspections and reply to various queries arising during the same.
To carry out the work imparted by supervisor as and when required
Handling TrackWise activity.
Responsible to perform role as per EHS SOP during Emergency.

Preferred candidate profile
Ready to shift to working location.
Ready to work in shifts

📌 Qa Executive Maharashtra (India)
🏢 SOLARA ACTIVE PHARMA SCIENCES
📍 India