Associate Manager - Quality Assurance

Preferred Education/ Qualification : B. Pharm/M. Pharm/M.Sc.

Experience : 6 – 8 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility /Technology Transfer/Validation.

Core Competencies :

• Technology Transfer of injectables
• Change Management process
• Risk assessments principles and tools
• Validation of manufacturing equipment’s
• Drug Product Process validations
• Regulatory requirements Compendial Changes
  
  

• Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis.
• Technical document review skills
• Knowledge in change control assessment
• Knowledge on manufacturing process such as stopper processing, sampling and dispensing, solution preparation, Component Preparation, Filling and Capping of Drug Product.
• Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc.,
  
  

• Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship
• Acts Decisively: Makes decision in a timely manner based on available information
• Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
• Critical thinking and Compliance mindset.
  
  

• Good performance, partially independent, reviews trends and data
• Responsible for review of Manufacturing documents such as SOPs, Process validation, cleaning validation, cleaning process verification documents, Batch manufacturing records, Exhibit batch plan, Exhibit batch Summary Reports. study protocols and reports.
• Tracking of change controls, Providing QA Impact Assessment, preapproval, post approval & closure of action items.
• Coordinating with CFT for addressing & resolving of Review Comments for timely Closure.
• Review of product & process related SOP, Job aids & Forms.
• Review and approval of NVPC, PH and conductivity.
• Review and approval of APQR’s.
• Report any non-compliance to the Supervisor
• Should have trouble shooting abilities in manufacturing Quality area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the Efficiency.