Quality Assurance- Executive

Glenmark Pharmaceuticals; Nashik District; On-site; INR 600,000 - 900,000; Full time

Job summary

Glenmark Pharmaceuticals in Nashik district seeks a capable professional to prepare protocols and reports for process validation, cleaning validation, packing validation and hold time studies. The role involves coordinating with IPQA, production and quality control to execute validation activities and track batch progress.

You will also prepare schedules for continuous process verification, perform verification as per SOP, and review statistical annexures and qualification reports to ensure

Qualifications

• Involvement in protocol and report preparation for process validation, cleaning validation, packing validation and hold time study.
• Coordinate with cross-functional teams (IPQA, production, quality control) for validation activities.
• Track batches for process validation, cleaning validation, packing validation and hold time study.
• Prepare schedules for continuous process verification and perform verification per SOP.
• Review statistical annexures of critical process parameters and yield in continuous verification reports.
• Prepare and review qualification / requalification protocols and reports, and monitor qualification activities.

Responsibilities

• Prepare protocol and reports for process validation and related studies.
• Coordinate validation activities with IPQA, production, and quality control teams.
• Track batches for validation and hold time studies.
• Prepare and review continuous process verification protocols and reports.
• Review statistics in continuous verification for KPIs and yield.
• Maintain qualification / requalification documentation and monitoring.

Job description

Job Description

• To prepare protocol and reports for process validation (Process Performance Qualification), cleaning validation, packing validation and hold time study.
• To co-ordinate with cross functional team like IPQA, production, quality control etc. for execution of validation and hold time activities.
• To track the batches for process validation, cleaning validation, packing validation and hold time study.
• To prepare schedule for continuous process verification. To perform continuous process verification for the product as per SOP. To prepare continuous process verification protocols and report of product.
• To review statistical annexures of critical process parameters, critical quality attributes and yield in continuous process verification reports.
• To prepare and review qualification / requalification protocol & reports, monitor the qualification activities.