Cadchem Laboratories Ltd
API Manufacturing
QA Jr. Executive / Executive
Qualification : B.Pharma / M. Pharma / Msc Chemistry
Experience : 3-4 Years in pharamceutical Company
1. Change Control ManagementResponsibilities:
- Initiate, review, and process Change Control proposals related to equipment, process, utilities, documents, and systems.
- Perform impact assessment (quality, regulatory, validation, and cross-functional).
- Coordinate with cross-functional departments (Production, QC, Engineering, Regulatory).
- Ensure timely closure of change controls with proper documentation.
2. Process ValidationResponsibilities:
- Prepare and review Process Validation Protocols and Reports (Prospective, Concurrent, Retrospective).
- Coordinate execution of validation batches with Production and QC.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Perform data analysis and ensure compliance with predefined acceptance criteria.
- Ensure adherence to cGMP and regulatory guidelines (e.g., EDQM, WHO).
3. Cleaning ValidationResponsibilities:
- Prepare and review Cleaning Validation Protocols and Reports.
- Define worst-case product selection and acceptance criteria
- Coordinate sampling with QC.
- Ensure cleaning procedures are validated and compliant.
- Monitor cleaning validation lifecycle and revalidation requirements.
- Review analytical results and trend data.
- Ensure compliance with regulatory expectations (e.g., cross-contamination control).
4. Equipment Qualification (DQ/IQ/OQ/PQ)Responsibilities:
- Prepare and review qualification protocols and reports (DQ, IQ, OQ, PQ).
- Coordinate qualification activities with Engineering and Production.
- Verify installation and operational parameters of equipment.
- Ensure calibration status and traceability.
- Maintain qualification status of equipment and requalification schedules.
- Review vendor documents and FAT/SAT reports.
- Ensure compliance with cGMP and data integrity requirements.
5. Utility QualificationUtilities Covered:
- HVAC System
- Water Systems (PW, WFI)
- Compressed Air
- Nitrogen
- Steam Systems
Responsibilities:
- Prepare and review utility qualification protocols and reports.
- Monitor critical parameters (e.g., temperature, pressure, microbial limits).
- Coordinate sampling and testing with QC.
- Ensure periodic requalification and system validation.
- Maintain utility system documentation and logs.
- Ensure compliance with regulatory standards (WHO, USFDA, EU GMP).
Pay: ₹25,000.00 - ₹35,000.00 per month
Work Location: In person
