QA Executive

2 weeks ago

Sachin, India Globela Laboratories Pvt Ltd Full time

**Job Title**: IPQA Executive

**Department**: Quality Assurance
**Location**: Sachin, Gujarat
**Experience Required**: 4-5 Years
**Qualification**: B.Pharm / M.Pharm / M.Sc. (Life Sciences or related field)

**Job Purpose**:
To ensure real-time quality assurance of manufacturing and packaging operations in compliance with GMP and regulatory standards, supporting consistent product quality and continuous improvement.

**Key Responsibilities**:

- Monitor and perform **line clearance**, **in-process checks**, and **critical control points** during manufacturing and packing operations.
- Verify and review **Batch Manufacturing Records (BMR)** and **Batch Packing Records (BPR)** for compliance and accuracy.
- Conduct **on-line sampling**, **IPC testing**, and **environmental monitoring** during batch processing.
- Monitor compliance to **cGMP**, **SOPs**, and **regulatory guidelines** on the shop floor.
- Handle and document **deviations**, **incidents**, and **change controls** as per quality systems.
- Ensure timely **closure of CAPA**, **investigations**, and **audit observations**.
- Collaborate with Production, QC, and Engineering departments for smooth and compliant operations.
- Participate in **internal audits**, **self-inspections**, and assist during **regulatory inspections** (USFDA, MHRA, WHO-GMP, etc.).
- Train junior staff on quality procedures and shop floor compliance.

**Key Skills and Competencies**:

- Strong knowledge of **cGMP**, **GDP**, and regulatory expectations.
- Proficiency in documentation and handling **GMP compliance records**.
- Experience in supporting audits and handling **regulatory compliance**.
- Good communication, analytical, and problem-solving skills.
- Flexibility to work in shifts and proactive on the shop floor.

Pay: ₹25,000.00 - ₹30,000.00 per month

**Benefits**:

- Paid time off
- Provident Fund

Schedule:

- Day shift

Work Location: In person

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