The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.
Job Responsibilities
- Preparation of Process validation protocol, Cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents.
- Preparation of Trending reports (Raw materials, Intermediates and Finished API) as per the schedule.
- Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring, Calibration Preventive Maintenance activities.
- Preparation, Review of protocols and reports for Equipment, Support system qualification.
- Execution and monitoring of Environmental monitoring Programs.
- Execution and monitoring of Temperature mapping study.
- Monitoring of Preventive Maintenance activities.
- Review of the executed BPCR s /GCR s and Manufacturing related documentation support.
- To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.
- To monitor and ensure the Dispatch activities initiated after the Quality release.
- Equipment and area clearance certification for product changeover.
- SAP transactions.
- Review of Analytical Test Data Sheets Tests Reports for finished products, Intermediates, impurity standards and reference standards.
- Preparation of certificate of analysis for impurity standards and reference standards.
- Retain samples maintenance.
- Quality Control Laboratory rounds for monitoring online GLP compliance.
- IPQA Activities in Manufacturing Packing
Job Requirements
- Education:
- M.Sc. / M. Pharma
- Knowledge, Skills and Abilities:
- To Follow cGMP, Knowledge on ICH Q7, Experience in regulatory inspection like USFDA, TGA MHRA etc
- Experience:
- 9 to 12 Years
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