Quality Assurance Executive

6 days ago

Salem, India Cologenesis Healthcare Pvt Ltd Full time

Qualification Requirements:
Education: Bachielor's or Master's degree in Life Sciences, Biotechnology, Microbiology, Biochemistry, or a related field.

Experience: 2-3 years of experience in Quality Assurance within the pharmaceutical, biotechnology, healthcare, or medical device industry.

Knowledge of:
Current Good Manufacturing Practices (cGMP) and Current Good Laboratory Practices (cGLP).

Regulatory standards such as FDA, MOR, WHO, ICH, ISO 13485.

Quality Management Systems (QMS), audits, CAPA, and document control.

Roles and Responsibilities:
Ensure adherence to cGMP and cGLP guidelines in manufacturing and laboratory processes.

Prepare, review, and update SOPs, protocols, and batch records to meet regulatory requirements.

Assist in regulatory and customer a11.Jdits, ensuring compliance with audit findings.

Ensure that Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) are issued in a controlled manner.

Assign unique batch numbers and maintain a record of issued documents.

Perform batch record review and product release verification.

Conduct internal audits and support external audit preparations.

Investigate non-conformities (NCs), Customer Complaints, Out-of-Specifications (OOS), and deviations.

Oversee line clearance verification before batch production.

Conduct training sessions for employees on cGMP, cGLP, SOPs, ISO 13485, and quality practices.

Implement Corrective and Preventive Actions

(CAPA) for process improvements.

Assign unique batch numbers and maintain a record of issued documents.

Perform batch record review and product release verification.

Conduct internal audits and support external audit preparations.

Investigate non-conformities (NCs), Customer Complaints, Out-of-Specifications (OOS), and deviations.

Oversee line clearance verification before batch production.

Conduct training sessions for employees on cGMP, cGLP, SOPs, ISO 13485, and quality practices.

Implement Corrective and Preventiv,e Actions

(CAPA) for process improvements.

Work closely with production and quality control teams for process efficiency.

Verify and approve the release of raw materials, intermediates, and finished products.

Ensure equipment calibration and Qualification compliance.

Pay: ₹15,000.00 - ₹23,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

Expected Start Date: 02/05/2025

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