Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Shift In Charge - Terminal Sterilisation
Job Description
• 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.
Candidate Profile
• 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
Additional Information:
Experience: Minimum 7 years
Location: Vizag
Education: B.Pharm or M.Pharm/M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Terminal Sterilisation
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