Executive – IPQA (In-Process Quality Assurance)
Location: Ahmedabad City, Gujarat, India
About the Role
The Executive – IPQA is responsible for ensuring compliance with cGMP (current Good Manufacturing Practices) and regulatory requirements in pharmaceutical manufacturing and packaging operations.
This role involves real-time quality monitoring, documentation review, sampling activities, and ensuring proper area and machine clearances to support the production of high-quality injectable pharmaceutical products.
Key Responsibilities
1. GMP Compliance & Shop Floor Monitoring
Ensure compliance with cGMP in manufacturing and packaging areas.
Conduct real-time monitoring of shop floor operations.
Supervise dispensing activities in manufacturing and packaging areas.
2. Documentation & Record Review
Review online and offline quality documents, including:
Equipment logbooks
Dispensing logs
Housekeeping records
Environmental monitoring records
Calibration records
Batch manufacturing/packaging records (BMR/BPR)
3. Sampling & Quality Checks
Conduct sampling activities such as:
Reserve samples
Stability samples
Perform in-process quality checks during batch execution and packaging.
Ensure adherence to batch packaging records (BPR) and stability protocols.
4. Material & Area Clearance
Provide machine clearance before production activities.
Ensure proper area clearance as per SOPs and GMP guidelines.
Oversee readiness of equipment and production areas.
5. Labeling & Batch Support Activities
Issue:
Bottle labels
Outserts
Medication guides for commercial batches.
6. Calibration & Instrument Control
Perform calibration of IPQA instruments.
Ensure instruments are maintained and compliant with quality standards.
7. Training & Compliance Support
Provide on-the-job GMP training to shop floor personnel.
Ensure documentation and quality systems are maintained in audit-ready condition.
Participate in investigations related to deviations or quality issues.
8. Communication & Reporting
Maintain strong written and verbal communication in English.
Report compliance status and quality issues in real time.
Educational Qualifications
Bachelor’s Degree (B.Pharm / B.Sc) – Required
Master’s Degree (M.Sc / M.Pharm) – Preferred
Experience Requirements
1–4 years of experience in pharmaceutical manufacturing / QA / IPQA roles.
Required Skills & Knowledge
Strong understanding of:
cGMP guidelines
Pharmaceutical manufacturing processes
Aseptic and injectable production environments
Knowledge of:
Batch manufacturing/packaging records (BMR/BPR)
Quality systems and documentation practices
Strong attention to detail and compliance mindset.
Personal Attributes
Strong observational and analytical skills.
High discipline and compliance orientation.
Ability to work in regulated production environments.
Good communication and teamwork skills.
Ability to handle pressure in manufacturing settings.
Summary
The IPQA Executive ensures real-time quality assurance and GMP compliance in pharmaceutical manufacturing, focusing on documentation review, shop floor monitoring, sampling, and supporting injectable drug production quality systems.
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