QO DP Tech III

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.  What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective Quality Assurance Drug Product Batch Record Review team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve change control activities to ensure compliance with configuration management policies. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It 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. Create, review and approve Good Manufacturing Practices {also cGMP} audit reports. Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's. Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact. Ensure that all documents received in the batch release area reviewed for completeness and accuracy. Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently. Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems. Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate. Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations. Help to define appropriate action plans for improvement and follow-up and communicate action closures. Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management. Maintain SOPs/OJTs/etc. for Manufacturing and Packaging records. Work with Operations to correct and reduce errors through effective communication and continuous improvement initiatives. Serve as audit support SME as needed. Drive continuous improvement initiatives to support the overall attainment goal. Support IMEX initiatives within the team. Utilize appropriate systems to complete tasks (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc…). Here Is What You Need (Minimum Requirements) Applicant must have a High School Diploma and 4+ years of experience Experience in pharmaceutical industry Experience in Quality administered systems Sound knowledge of current Good Manufacturing Practices {part of GxP} Ability to work in a team environment within own team and interdepartmental teams Effective written and oral communication skills Bonus Points If You Have (Preferred Requirements) Experience at a manufacturing site Experience of writing and managing deviations Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management Experience with the following