Senior Executive – IPQA EM (In-Process Quality Assurance – Environmental Monitoring)
Location: Ahmedabad, Gujarat, India (Pharmez SEZ & Associated Manufacturing Units)
Department: Quality Assurance – Sterile Injectables
Employment Type: Full-Time
Role Overview
A leading sterile pharmaceutical manufacturing organization is seeking a Senior Executive – IPQA EM to ensure robust in-process quality assurance and environmental monitoring compliance across manufacturing and packaging operations. This role plays a critical part in maintaining cGMP adherence, regulatory readiness, and real-time quality oversight within injectable production facilities.
The incumbent will be responsible for shop floor QA supervision, documentation review, aseptic compliance monitoring, and batch packaging oversight to support the consistent production of high-quality injectable pharmaceutical products.
Key Responsibilities
In-Process Quality Assurance & Shop Floor Compliance
Ensure cGMP compliance across manufacturing and packaging areas
Perform real-time monitoring of shop floor activities during sterile production
Supervise dispensing activities within manufacturing and packaging areas
Provide machine clearance and area clearance prior to batch execution
Issue bottle labels, outers, and medication guides for commercial batches
Sampling & Environmental Monitoring
Conduct reserve sample, stability sample, and in-process sampling as per Batch Packaging Records (BPR) and stability protocols
Review environmental monitoring records and ensure compliance with aseptic standards
Perform in-process checks during batch packaging execution
Documentation & Record Review
Conduct online and physical review of:
Equipment logbooks
Dispensing logs
Housekeeping records
Environmental monitoring records
Calibration records
Batch manufacturing and packaging records
Ensure IPQA documents remain inspection-ready at all times
Quality Systems & Compliance Support
Calibrate IPQA instruments as per defined schedules
Participate in deviation investigations, root cause analysis, and CAPA implementation
Support change control processes and regulatory audits
Deliver on-the-job GMP and documentation training to shop floor personnel
Prepare compliance reports and support audit readiness initiatives
Educational Qualification
Master’s Degree (M.Sc.) in Microbiology
Experience Required
Minimum 2–4 years of experience in In-Process Quality Assurance (IPQA) or IPQC within sterile or injectable pharmaceutical manufacturing
Hands-on experience in aseptic process monitoring and shop floor QA oversight
Practical exposure to deviation handling, investigations, and CAPA management
Experience working in regulated manufacturing environments compliant with cGMP standards
Required Skills & Technical Competencies
In-Process Quality Control (IPQC) – Advanced proficiency
Strong knowledge of cGMP and global regulatory requirements
Aseptic process monitoring and sterile compliance expertise
Line clearance and batch record review mastery
Deviation, investigation, and CAPA management capabilities
Change control management knowledge
Equipment and facility qualification awareness
Strong root cause analysis and investigation skills
Analytical quality assurance expertise
Effective written and verbal communication skills in English
Work Location
Plot No. 15,16,17, Pharmez Special Economic Zone (SEZ), Ahmedabad, Gujarat, India
Additional associated pharmaceutical manufacturing site in Gujarat
Experience Level
Mid-Level Professional (2–4 Years of IPQA Experience in Sterile / Injectable Manufacturing)
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