QA Officer

Job Description:

Position:        QA Officer

Location:        Vapi

Experience:    2 - 5 Years

Industries:     Pharma

Responsibilities:        

• Documentation & Record Review:
• Review specifications, sampling instructions, test methods, and analytical reports.
• Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records.
• Review completed Batch Production Records and Laboratory Control Records post-batch completion.
• Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports.
• Review and finalize Certificate of Analysis (CoA) for finished products.
• Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports.
• Review Standard Operating Procedures (SOPs) and Annual Product Quality Review (APQR) reports.
• Batch Release & Plant Compliance:
• Responsible for batch release in accordance with company SOPs and regulatory requirements.
• Perform regular plant rounds and monitor daily compliance in production, QC, and warehouse areas.
• Ensure finished goods dispatch is in line with quality requirements.
• Validation & Qualification:
• Preparation, execution, and review of Cleaning Validation Protocols and Reports.
• Preparation of Clean and Dirty Equipment Hold Time Study Reports.
• Conduct Campaign Cleaning Validation and monitor validation batches.
• Review of Validation Protocols/Reports and Equipment Qualification Protocols/Reports.
• Toxicology Data collection and PDE (Permitted Daily Exposure) value calculations.
• Audit & Regulatory Compliance:
• Plan and execute Internal Audits as per defined schedules.
• Ensure closure of audit observations through CAPA management.
• Handle deviations, change controls, and market complaints in coordination with relevant departments.
• Liaison with external auditors and regulatory bodies during audits/inspections.
• Cross-functional Coordination:
• Coordinate with Production, Quality Control, Engineering, and Warehouse departments for validation and quality-related activities.
• Support validation and qualification activities during product scale-up or technology transfer.

Required Skills:

• Strong understanding of GMP, ICH, FDA, and regulatory guidelines.
• Documentation accuracy and attention to detail.
• Strong interpersonal and communication skills.
• Proficient in handling Quality Systems (Deviations, CAPA, Change Control).

Required Qualification: - B.Sc/M.Sc/B.Pharm/M.Pharm - Chemistry        

Salary: - Upto 4.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-