Sr. Associate Quality Assurance

Job Description:

Responsibilities

• Change Management process
• Risk assessments principles and tools
• Validation of manufacturing equipment’s
• Drug Product Process validations
• Regulatory requirements
• Advanced Competencies:
• Strong Interpersonal skills
• Ability to communicate effectively with all levels within the organization.
• Compliance driven approach , knowledge on cGMP and regulations.
•  Knowledge in validation principles and practices related to the Equipment & Utility Qualifications, Water system, HVAC system. 
•  Understanding of Drawings and layouts of manufacturing area, air flow, material flow, personal flow, building management system for real-time monitoring of manufacturing areas. 
•  Fundamental knowledge on manufacturing activities like dispensing, solution preparation , filling, terminal sterilization, visual inspection, labelling and packing. 
•  Understanding of design and engineering aspects, basic knowledge of equipment construction, working principle and maintenance of equipment. 
•  Knowledge of various Quality tools required for investigations
•  Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization. 
•  Knowledge in Change control assessment

Qualification & Experience

• B.Pharm/M.Pharm/M.Sc
• Experience: 6-8 years of experience in Validation/Maintenance / Engineering/ Quality.