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.
Post : Investigation lead for Visual inspection
• Liaise with Site / Corporate Quality function to represent Vizag site for Global procedural improvements.
• Manage investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.
• Ensure investigations are evaluated and closed out in a timely manner to meet business needs.
• Ensure Quality Management System (Procedures, Records, Investigations, etc.) for the investigations department are followed and maintained.
• Conduct or participate in major investigations and as required.
• Ensures the Investigations section is maintained as a safe working environment.
• Leading a team of investigators.
• Act as stand in for the Investigations Manager in absence or as assigned by that manager.
• In the absence of the Investigations Supervisor, the role will be delegated to a direct/ indirect report of this position as assigned.
• Coordinate and direct product disposition with respect to the impact ascertained in accordance to agreed targets and procedures to meet business needs.
• Provide direct input or coaching support for other functional groups in investigations.
• Review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected GXP standards.
• Prepare and approve regular reports on department performance and quality issues.
• Evaluate data, trends, and report results to manager.
• Implement measures to meet and• exceed the service• delivery of defined aspects of Investigations department.
• Responsible for handling of investigations related to the visual inspection.
• Responsible to ensure the team is meeting the requirement of procedure for IA and closure.
• Maintain the closure matrix to above 90% without the extension.
• Completion of training and responsible for their team members training completion.
• Knowledge of Current regulatory requirements (Typically USFDA)
• Thorough knowledge of c GMPs.
• Knowledge of various quality tools of investigations.
• Sterile manufacturing experience preferred.
• Experience in explaining investigation in regulatory audits/inspection.
• Should have good technical writing.
• Good understanding of quality systems.
B.Pharm/M.Pharm/M.S (Pharmacy) Preferably 7-10 years of experience of investigation in Production / Quality Assurance / Quality Control function of STERILE manufacturing facility
Experience : 7-10 years
Qualification : B.Pharm/M.Pharm/M.S
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th May, 2021
See All Other Jobs in our Database