Associate Manager Quality Assurance & Control | Pfizer | Vizag

Job Description

Roles and Responsibilities

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
• Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
• Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Pfizer Quality standards and Regulatory requirements.
• Prepare and participate in Manufacturing and Supplier Quality Assessment Audits (MSQA) and BOHs Inspections to the site, ensuring successful results, and timely implementation/closure of action plans, identify and manage routine Customer Quality complaints for commercial Drug Products in the global complaints management system (PCOM) and interactions with the Contractor Quality organization if needed for ensuring that the investigation reports are appropriate and acceptable.
• Assist Quality Control lab Supervisor with technical issues involving injector functionality, component testing, and protocol execution.
• Contribute to quality assurance management team initiatives and objectives.
• Assist in the process of gathering, interpreting, and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files, and presentations.
• Implement and adhere to {Current} Good Manufacturing Practices {part of GxP} regulations and company policies.
• Conduct detailed audit testing in connection with the investigation of allegations of expense report fraud, conflicts of interest, and other violations of Pfizer policies and procedures or laws.
• Assist in the review of area documentation and perform trend analysis on data, controls, and standards.

Qualification: 

Must-Have

• Bachelor’s Degree
• 7+ years’ experience
• Demonstrated experience and skills in conduct and documentation of quality investigations related to pharmaceutical/medical device manufacturing processes
• Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validations, engineering drawings and basic statistical processes
• Ability to understand and apply Quality Engineering tasks, and mathematical concepts especially as it relates to statistics and probability
• Good technical writing skills, and communication as well as presentation skills
• Having Good experience in equipment qualification and process knowledge.
• Working knowledge of Microsoft Office, Microsoft Projects, and Statistical Software.

Nice-to-Have

• Master’s degree
• Complaint investigation experience
• Experience with electronic laboratory systems