Officer – IPQA (In-Process Quality Assurance)
Location: Ahmedabad City, Gujarat, India
About the Role
The Officer – IPQA is responsible for ensuring compliance and quality monitoring in pharmaceutical manufacturing cleanroom environments. The role focuses on environmental monitoring, documentation review, and participation in qualification and validation activities to maintain GMP compliance.
Key Responsibilities
1. Environmental Monitoring
Perform environmental monitoring of manufacturing cleanroom areas as per defined schedule.
Conduct:
Non-viable particle monitoring
Compressed air monitoring
Nitrogen gas monitoring
Personnel monitoring
Review environmental monitoring trends and reports.
2. Documentation & Quality Review
Review environmental monitoring data and water trends.
Review calibration certificates and related documents.
Review media fill documentation (CD).
Ensure compliance with defined quality systems and procedures.
3. Material Handling & Coordination
Receive required resources for environmental monitoring from the microbiology lab, including:
Plates
Samplers
Swabs
Ensure proper usage and handling in aseptic areas.
Return used materials to the microbiology lab for further processing along with completed documentation.
Maintain issuance and reconciliation records of environmental monitoring materials.
4. Qualification & Validation Activities
Participate in media fill simulation studies.
Assist in qualification activities within the manufacturing area.
Support validation processes related to cleanroom operations.
Educational Qualifications
Master of Science (MSc)
Required Skills & Knowledge
Understanding of Good Manufacturing Practices (GMP).
Knowledge of aseptic manufacturing environments.
Familiarity with:
Environmental monitoring systems
Cleanroom classification standards
Microbiological sampling techniques
Strong attention to detail and documentation accuracy.
Personal Attributes
High level of responsibility and discipline.
Strong observation and analytical skills.
Ability to follow strict compliance procedures.
Good organizational skills.
Ability to work in regulated manufacturing environments.
Summary
This role ensures the quality, sterility, and compliance of pharmaceutical manufacturing environments through continuous monitoring, documentation, and participation in validation activities.
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