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Shift In Charge


Visakhapatnam, AP 530003
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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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