Assistant Manager-Quality Assurance @ Kardanur

MSN Group

12 - 15 years

8 - 11 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

QMS Audit Compliance Validation Testing Vendor Qualification Change Control

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Vendor Qualification & Management:
Evaluate, qualify, and maintain vendor/supplier compliance with applicable standards and regulatory requirements.
Audit Planning & Execution:
Plan, prepare, and execute various types of audits including internal, external, regulatory, and third-party audits. Ensure timely closure of audit observations.
Quality Management Systems (QMS):
Implement, maintain, and improve QMS practices in alignment with cGMP and global standards. Oversee documentation, deviation management, CAPA, and training programs.
Regulatory Compliance:
Ensure site-wide compliance with global regulatory standards such as cGMP, ICH guidelines, and ISO 9001:2015. Participate in inspections and ensure readiness.
Validation Activities:
Lead and support Process Validation and Cleaning Validation activities. Ensure protocol and report preparation, execution, and review are as per regulatory expectations.
Equipment & Instrument Qualification:
Oversee and review qualification of equipment, instruments, and systems in coordination with cross-functional teams.
Risk Assessments & Change Control:
Conduct risk assessments and manage change control activities with appropriate impact analysis and documentation.

Desired Skills:

Strong knowledge of API manufacturing QA systems
Exposure to global regulatory audits (e.g., USFDA, EU, WHO)
Proficient in documentation, investigation writing, and root cause analysis
Excellent communication and leadership skills

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