QA Officer

3 days ago

Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

**Title/Designation**:QA OFFICER

**Based at**:Ahmedabad

**Industry**:Class III Medical Device manufacturing

**Qualification**:B.Pharma

**Experience**:Min. 0 to 0.6 Months Class III medical devices
- Ensure the compliance of SOP’s and records in work place
- Identify deviations in established validated process and report to concerned department and superior
- Monitor the compliance of proper discipline, personal hygiene and entry and exit procedure in working area as per SOP
- Ensure identification number to machine, instruments and equipment as per SOPs
- Responsible for verification of BMR and BPR inline filling, inspection of Finished Products in coordination of production team.
- Follow Good Documentation Practices in plant (GDP)
- Conduct training on SOPs as per schedule
- Identify deviation, change and gap from the plant for improvement of Quality of Product.
- Ensure effective pest control activities in the premises
- Participate in conducting of stability studies, validation of processes/products and qualification/calibration of instruments/equipments as per schedule.
- Other responsibilities allotted by Quality Head/QA Executive as and when required
- Follow the established guidelines and procedures related to quality of the medical device and implement it as applicable
- Checking of artwork, labelling and promotional material before use
- Checking of Barcode and UDI for device traceability
- Checking of BMR, BPR, and other records and maintenance of good documentation practices
- Ensure effectiveness of Change control, deviation, OOS, OOT, Non-conformance form, CAPA, CIR
- Ensure Process and Equipment Validation, Qualification, Calibration and maintenance as per schedule

**Job Types**: Full-time, Regular / Permanent, Fresher

**Salary**: ₹280,000.00 - ₹300,000.00 per year

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

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