Executive / Senior Executive – IPQA EM (In-Process Quality Assurance – Environmental Monitoring)
Location: Ahmedabad, Gujarat, India (Pharmez SEZ & Associated Manufacturing Sites)
Department: Quality Assurance
Employment Type: Full-Time
Role Overview
A leading pharmaceutical manufacturing organization is seeking a qualified Executive / Senior Executive – IPQA EM to strengthen its In-Process Quality Assurance (IPQA) and Environmental Monitoring (EM) operations. This role is critical in ensuring compliance with aseptic manufacturing standards, regulatory guidelines, and internal quality systems within sterile production facilities.
The position is based in Ahmedabad, Gujarat, and requires hands-on expertise in environmental monitoring across classified aseptic areas (Grade A, B, C, and D).
Key Responsibilities
Conduct environmental monitoring (EM) in sterile and aseptic manufacturing areas
Perform aseptic area behavior monitoring and ensure adherence to GMP practices
Operate and manage environmental monitoring instruments such as NVPC and MAS
Execute personnel monitoring activities within classified areas
Perform microbial trend analysis and prepare detailed compliance reports
Ensure proper sampling, sample handling, and documentation as per SOPs
Support internal audits, regulatory inspections, and quality investigations
Maintain data integrity and ensure compliance with cGMP, EU GMP, and USFDA standards
Educational Qualification
M.Sc. in Microbiology or
B.Pharm from a recognized institution
Experience Required
3–4 years of relevant experience in Environmental Monitoring (EM) within aseptic pharmaceutical manufacturing
Hands-on exposure to classified cleanroom environments (Grade A, B, C, and D)
Experience in sterile injectable or aseptic process facilities preferred
Familiarity with regulatory expectations related to environmental monitoring and sterile compliance
Required Skills & Competencies
Strong understanding of aseptic processing and contamination control strategies
Practical knowledge of environmental monitoring instruments (e.g., Non-Viable Particle Counter (NVPC), Microbial Air Sampler (MAS))
Expertise in microbial trend analysis and documentation practices
Good analytical and problem-solving skills
Strong knowledge of cGMP, data integrity, and sterile manufacturing compliance
Effective communication and teamwork abilities
Work Location
Plot No. 15,16,17, Pharmez Special Economic Zone (SEZ), Ahmedabad, Gujarat, India
Additional associated manufacturing site within Gujarat
Experience Level
Mid-Level Professional (3–4 Years of Environmental Monitoring Experience in Aseptic Pharmaceutical Manufacturing)
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