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.

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Quality Assurance and Control