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Shift In Charge

Pfizer


Location:
Visakhapatnam, AP 530003
Date:
01/19/2018
2018-01-192018-02-19
Pfizer
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Job Details

+ Required Qualification : Bachelors in Pharmacy with Minimum 7 years experience in Sterile Injectable manufacturing - with specific exposure to Autoclaves



+ Desired Qualification : Masters degree preferred with knowhow of Terminal sterilizers



+ Execute and coordinate responsibilities that include manpower allocation, ensuring the completeness of activity as per respective procedures



+ Single point accountability for all the activities in respective shift which includes safety, quality and compliance issues.



+ Ensure that terminal sterilisation and its related documentation is completed within the desired shift







**Equipment installation and Qualification**







+ Participate in execution of installation FAT,SAT,IQ,OQ,IOQ,PQ of new equipment in the respective functional area



+ Participate in the execution of periodic requalification and process validation and ensure that the activities are completed with minimal deviations in place **Operations**



+ Ensure terminal sterilization as per procedures.



+ Activity planning and deploying the personnel according to the plan.



+ Ensure area upkeep with adequate identification of machines and materials



+ Conduct real time batch record review in assigned area



+ Enforce discipline of the personnel working in the process area



+ Ensure compliance of change room behavior and personal hygiene to procedures



+ Ensure adequate cleaning, sanitization of the equipment and area and housekeeping



+ Ensure avoidance of cross contamination and / or mix ups



+ Coordinate supporting functional departments for smooth operation of production activity



+ Ensure all the performed activities comply with respective procedures.



+ Ensure the completeness of documentation for all performed activities.



+ Review of all related protocols (Qualification/Non Routine Validations/ Trial Run Protocols).



+ Initiating CCFs related to documents, equipment. Ensuring their closure and implementation of the changes within specified time



+ Ensure training compliance for housekeeping personnel / contractors as per the requirement.



+ Identify deviations/exceptions and escalate to Manager by appropriate procedures.



+ Active participation in the investigations related to exceptions and during equipment maintenances.



+ Disposal of rejects and waste generated during processing and other related activities.



+ Initiate and assist with ER investigations as applicable and ensure that they are closed on time



+ Monitor assigned area for compliance to SOPs and cGMP



+ Adherence to safety procedures/GMP & GDP practices



+ Preparation of trial run protocols related to exceptions.



+ Raise requests to Engineering in the event of breakdown / maintenance - certify the same after completion.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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