Executive - QMS

Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)

3 - 5 years

3 - 5 Lacs

Bengaluru

Posted:5 days ago| Platform:

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Skills Required

21 CFR Part 11 Impact Assessment QMS Documentation IT Compliance CAPA LIMS GAMP 5 ERP Deviation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Proffered Profile:

Key Responsibilities:

Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS.
Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, etc.).
Collaborate with QA, Validation, and Business teams for development, qualification, and maintenance of IT systems as per CSV and QMS guidelines.
Manage QMS elements such as deviations, CAPAs, change controls, audit trails, and periodic reviews.
Participate in internal/external audits; coordinate documentation, evidence, and responses.
Conduct IT quality risk assessments and support necessary remediation.
Maintain accurate records of compliance activities, including SOP training and validation documentation.
Deliver training programs to IT teams on QMS processes and compliance awareness.
Support full lifecycle management of computerized systems (planning, validation, operation, retirement).
Assist with vendor qualification and assessments for IT-related services.

Required Skills and Qualifications:

3 - 5 years in IT compliance/QA/validation in a regulated industry
Working knowledge of ISO 9001, GAMP 5, 21 CFR Part 11, EU Annex 11
Familiar with LIMS, ERP, MES, DMS systems
Strong documentation and analytical skills
Good understanding of ALCOA+ and data integrity

Preferred Certifications:

ISO Lead Auditor, Six Sigma, or other Quality Management certifications

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