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Executive

Evolet Healthcare

2 - 4 years

2 - 3 Lacs

Gurugram

Posted:4 hours ago| Platform:

Apply

Skills Required

QC COAs GDP vendor coordination Regulatory Knowledge & Compliance organizational skills In-Process Quality Assurance Corrective and Preventive Actions GMP regulatory guidelines QMS Implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Review and approve Finished Goods and corresponding Certificates of Analysis (COA).

Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant

departments.

Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints.

Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints.

Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes.

Maintain strict adherence to Good Documentation Practices (GDP).

Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities.

Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.)

Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring.

Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

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Executive

Experience & Salary

Skills Required

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Job Type

Job Description

Role & responsibilities

Review and approve Finished Goods and corresponding Certificates of Analysis (COA).

Maintain detailed records of received samples in an organized manner. Ensure proper allocation and storage of approved COAS in the shared drive. Verify and confirm drug product permissions as per regulatory requirements. Oversee the finalization of packing materials in coordination with relevant

departments.

Conduct audits of new vendors, ensuring compliance with quality standards. Ensure proper implementation of Corrective and Preventive Actions (CAPA) for any deviations or complaints.

Visit manufacturing sites to address and investigate market complaints effectively. Coordinate with manufacturing partners for handling market and sample-related complaints.

Perform joint analysis of complaint samples in collaboration with manufacturers to identify root causes.

Maintain strict adherence to Good Documentation Practices (GDP).

Possess sound knowledge of Schedule M, USFDA, MHRA and ensure compliance in relevant activities.

Sound knowledge of IPQA (In-Process Quality Assurance) activities across different dosage forms (e.g., tablets, capsules, syrups, ointments, etc.)

Sound knowledge of different types of SOPS (Standard Operating Procedures), including preparation, review, implementation, and compliance monitoring.

Basic understanding of QMS (Quality Management System), including its elements and relevance in pharmaceutical operations.

More Jobs at Evolet Healthcare

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