Quality Engineer - Validation

Healthium Medtech

6 - 8 years

4 - 5 Lacs

sri city

Posted:3 days ago| Platform:

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Skills Required

batch records machine validation preparation of protocols calibration software validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Preparation of protocols in line with international standards and executing the heat-sealing machine validation as per the defined frequency.
Preparation of protocols in line with ISO 11135 & ISO11137 for the EO & Gamma radiation sterilization process validation and executing the validation activities.
Preparation of protocols as per international standards and executing the validation activities for all the manufacturing & testing processes.
Co-ordinating with maintenance team and other teams to prepare the IQ & OQ protocols and reports.
Co-ordinating with external service provider to complete the software validations.
Conducting the in-house calibrations as per the defined protocols.
Co-ordinating with external service providers to conduct the cleanroom validations as per ISO 14644.
Co-ordinating with external service providers to conduct the calibration for all the equipments as per the defined frequency and keeping the reports are upto date.
Co-ordinating with external service providers to conduct the thermal mapping for the incubators, stability chambers, cleanrooms & storage areas as per the defined frequency and keeping the reports are upto date.
Keeping all the documents related to validation and calibration ready to face the announced & unannounced audits.
Keeping all the documents related to validation and calibration ready to face the customer & regulatory audits.
Approval of batch records.
Plan and conduct vendor audits.
Strict adherence to EHS policy and EHS procedures.
Perform batch reconciliation of batch manufacturing records for finished product batch release.

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