Sr. Associate Compliance - Visakhapatnam/Vizag @ Pfizer

5+ Years of experience in documentation

• Ensure compliance to GDP and ALCOA Principles during document preparation.
• To prepare the Quality Risk assessment for the equipment and process, tracking for the implementation of QRM mitigation plan
• Responsible for the Preparation of Master manufacturing records and Master Packing records for the commercial batches.
• Responsible for the CCF initiation, coordination with CFT for impact assessment and CCF pre-approval, responsible for closure of CCF.
• Procedural updation as per approved CCF and ensuring PLS upload.
• Monitoring of action items addressed in the CCF and closure as per the timelines mentioned in CCF
• Responsible for review of commercial, scale up, exhibit, intended and Process validation master manufacturing records and packing records.
• Preparation of response for audit observations, propose CAPA taking consent of SME, owner, and QA for identified action items.
• Track the activity related to response and send update to owner

• Interact with investigator for CAPA plan and support in investigation