Sr. Associate Quality Assurance

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

Experience: 6-8 years of experience in Validation/Maintenance / Engineering/ Quality.

Core Competencies:

• 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.

Technical Skills:

• 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

Behavioral/Any Other Skills:

• Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship.
• Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.
• Written communication: Ability to write well-Structured technical reports.
• Holds people accountable: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; Monitors process, progress and results
• Acts Decisively: Makes decision m a timely manner based on available information.
• Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
• Grows others: Provides challenging and stretching tasks and assignments.
• Self-accountable & Proactive approach.
• Critical thinking and Compliance mindset.

Work Location Assignment: On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control