Use Your Power for Purpose Everything we do every day is driven by an unwavering commitment to delivering protected and effective products to patients Our science and risk-based compliant quality culture is both flexible and innovative always putting the customer first Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients Our dedication to quality and safety ensures that every product we deliver meets the highest standards and your role is crucial in maintaining this excellence What You Will Achieve In this role you will Be responsible to lead downstream manufacturing compliance Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements Handling Change control management system including CCF impact assessment preapproval cross functional CCF evaluation monitoring of closure of change controls and change control action item Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA Responsible for the review and approval of Master manufacturing records for the commercial batches Responsible for review and approval of scale up exhibit intended and Process validation master manufacturing records To review and approve the quality risk assessment for the equipment and process Responsible for compliance to audit observation tracking and implementation of audit commitment action items Monitoring training metrics on daily basis for all the production employees with on time training without past dues Continue to ensure stock availability of all consumable material for production Responsible for review of compendial assessments Responsible for the review and approval of trends and APQR Responsible for the review of SQRT slides for the trends Coordinate with QA documentation and production for issuance and retrieval of document to and from production Support site inspection readiness prog

📌 Senior Team Leader (Kadapa)
🏢 Pfizer
📍 Kadapa