QA Executive/Assistant Manager Job Opening @ Zydus
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Job Title:Â QA Executive/Assistant Manager
No.of posts: 01
Eligibility: M Pharma, B Pharma
Job Description
- Equipment, Utilities and Area qualification for the Oncology and General OSD Facility.
- Preparation and execution of qualification protocols along with support team.
- Compilation of the data and preparation of final qualification report.
- Equipment re-qualification wherever and whenever required.
- Review of water analysis Trends.
- Review and Verification of Preventive Maintenance
- Review of third party calibration certificates.
- Ensuring PMP/Calibration status of the Equipments/Instruments
- Tracking of validation planner and routine validation of equipments /Protocol revisions.
- Handling of Change Control (CC), Deviations, and incidents Reports.
- Conduct the self-inspection audit of the department as per the schedule and to ensure and review the compliance of observation during self-inspection.
- Any additional job assigned by section in charge with proper training.
- Responsible for in process Quality Assurance activities & compliance of cGMP in manufacturing area.
Online review of the GMP documents like Balance verification record, Temperature & % Relative Humidity Record, Differential area air pressure record and equipment sequential log. - To ensure in process parameters during granulation, compression, coating, imprinting stage and packaging.
- To carry out AQL inspection.
- To perform the operations, calibration and ensure Calibration status of D.T., Hardness Tester, Friability Test Apparatus, Halogen Moisture Analyzer, Analytical balance, Vernier caliper and Torque tester .
- Review and approval of Batch Manufacturing record and Batch Packaging Record.Review,
- Preparation and approval of Sampling protocol.
- Responsible for Collection of In Process Samples and Finished Samples as per sampling protocol.
- Ensuring the product sampling as per SOPs and to collect validation samples as per frequency and procedure defined in process validation protocol.
- Handling of Hold Time study samples and Swab sampling for cleaning validation.
- Review and Verification of Preventive Maintenance
- To carry challenge tests of all packing machines as per frequency defined in SOP.
Responsible for collection of QP Samples, Stability samples and retained samples during packaging stage. - Ensuring PMP/Calibration status of the Equipments/Instruments
- Preparation and execution of qualification protocols along with support team.
Conduct the self-inspection audit of the department as per the schedule and to ensure and review the compliance of observation during self-inspection. - Identification and preparation of new SOP’s as per current requirements.
- Preparation, Review and drafting of SOPs pertaining to QA department.
- Any additional job assigned by section in charge with proper training.
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