Executive QA-api

2 days ago

Ankleshwar, India Sensys Technologies Pvt. Ltd Full time

We are hiring QA executive.

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

Qualification - bsc / msc chemistry

Salary - 4 to 5 lakh **no more than this P. A**

Location - Ankleshwar

Only male

**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 SOPs
- Distribution, 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.
- To Support the head of department in the environmental management work and reporting to head of Department with regard to how the environmental management work is continuing.
- Investigation of deviation/incident related to Environment management with co-ordination with head of department.

**Job Types**: Full-time, Permanent

Pay: ₹500,000.00 per year

Schedule:

- Day shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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