Associate Manager - MQA

Job Description:

Responsibilities

• Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
• Maintain regulatory compliance in accordance with cGMP practices
• Ensure manufacturing policies and procedures conform to Pfizer standards
• Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.
• Review of Batch reports, and Equipment audit trails
• Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products
• Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.
• Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
• Perform Daily walkthroughs and report observations to the Sr. Team leader.
• Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.

Qualification & Expeirence

• Candidate must have B. Pharm, M. Pharm, MSc. with 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.