Quality Assurance Executive

1 week ago

Ankleshwar, Gujarat, India Talent Trace Consultancy Full time
Position – QA executive.

Experience – 4 or 5 years only pharma line (API experience )

CTC:
5LPAStrong knowledge of QMSLocation – Ankleshwar

RESPONSIBILITIES:


To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material.

Assistance in preparation of SOP of various departments/ preparation of draft SOPs.
During plant round QA Executive to verify documents as per cGMP and GLP norms.
Line Clearance activities for manufacturing and packaging before process starts.

To issue the deviation form, Change control form, Out of Specification form, Customer complaint form, OOT form, investigation for etc.

as per request from respective dept.
Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA verification and release of finish product.

To prepared documents & records and monitoring of activities as per SOPsDistribution, retrieval and control of SOPs, documents/records of all dept.

To participate the internal audits, customer audit, regulatory inspection.
To Attend QR meeting as per schedule.
To ensure data integrity as per procedure.
To review manufacturing, store, QC activity.
To prepare approved vendor list and maintain vendor qualification.
Conduct traceability Activity.
Preparation and maintain CAPA log.

To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.

To collect data and prepare the annual product review.
To witness and verify of process validation, cleaning validation and equipment qualification and to prepare protocol and report.

Returned Material:
Investigate and make investigation report and maintain the record

Product complaint:
Investigate and make investigation report and maintain the record.
Ensuring compliance of the systems used for maintaining the equipments and calibrating equipment /instruments/ preparation of schedule.
To prepare template or record format as per respected SOP and issuance.
To prepare a schedule and conduct training on cGMP, GLP and evaluation of the training.
Providing training to all concerned on cGMP and on job specific or based on needs identified.
Any other assignment /work allocated by Head QA.To ensure disposal of waste is carried out as per procedure.

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