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 : MQ TS Downstream Senior Specialist
Job Description
• Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
• Maintain regulatory compliance in accordance with cGMP practices
• Ensure manufacturing policies, procedures conform to Pfizer
• SME for Terminal Sterilization/Visual Inspection/Packing.
• Knowledge and hands on experience in reviewing eBR.
• Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
• Perform Daily walkthroughs and report observations to the Supervisor and ensure appropriate closure of those incidents
• To provide trainings to colleagues on Terminal Sterilization/Visual Inspection/Packing process and equipment.
• Report any non-compliance to the Supervisor
• To perform manufacturing investigations, implementation of CAPAs and to provide support to other investigators for technical inputs.
• Provides guidance to and may lead moderate to complex projects
• Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.
• Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Experience in handling regulatory, corporate and internal auditors/ inspectors.
Candidate Profile
B. Pharm / M.Pharm / M.Sc (Any Specialization)
8 - 10 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
Additional Information
Qualification : B.Pharm / M.Pharm / M.Sc
Experience : 8-10 years
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : MQ TS Downstream
End Date : 25th October, 2018
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