Executive Sr. Executive- IPQA (Sterile)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Role Objective
To ensure compliance with cGMP regulatory guidelines and company SOPs during manufacturing and packaging of injectable formulations. The role involves real-time monitoring of production activities line clearance documentation review and ensuring product quality at every stage.
Key Responsibilities
- Perform line clearance before start of manufacturing and packaging operations.
- Conduct in-process checks during compounding filtration filling sealing and lyophilization of injectables.
- Monitor critical parameters (temperature pressure environmental conditions) during aseptic operations.
- Ensure adherence to SOPs batch records and regulatory requirements.
- Review and verify logbooks batch manufacturing records (BMRs) and batch packaging records (BPRs).
- Report and document deviations change controls and non-conformances.
- Support media fill validation environmental monitoring and sterility assurance programs.
- Coordinate with production and QC teams to resolve quality issues in real time.
- Participate in internal audits regulatory inspections and training programs.
Qualifications
- / / (Microbiology Biotechnology Chemistry).
- 2–5 years of experience in IPQA for sterile/injectable formulations.
- Strong knowledge of cGMP WHO EU and USFDA guidelines.
- Familiarity with aseptic techniques cleanroom practices and sterile manufacturing processes.
Desired Skills
- Attention to detail and strong documentation practices.
- Ability to work in aseptic environments with precision.
- Good communication and cross-functional collaboration skills.
- Problem-solving mindset with focus on compliance and product quality.
Why Join Us
- Exposure to state-of-the-art sterile manufacturing facilities.
- Opportunity to work with global regulatory standards.
- Career growth in a high-demand niche of pharma quality assurance.
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