Monday, 22 July 2019

Zydus Cadila Urgent Opening for QA SR. EXECUTIVE/ASSISTANT MANAGE


Zydus Cadila Urgent Opening for QA SR. EXECUTIVE/ASSISTANT MANAGE




Alembic Pharmaceuticals Limited - Urgent Opening for QA SR. EXECUTIVE/ASSISTANT MANAGER



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.

Post :-   QA SR. EXECUTIVE/ASSISTANT MANAGER
Qualification :- B. Pharma, M. Pharma
Experience : - 4 - 5 Years
Company Profile:- 
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide and is dedicated to creating healthier communities globally.

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