Quality Assurance and Regulatory Affairs activities
.
Key Responsibilities:
Ensure compliance with
GMP, SOPs, and regulatory guidelines
.
Prepare, review, and maintain
QA documentation
including SOPs, BMR, BPR, protocols, and reports.
Handle
deviations, change controls, CAPA, and investigations
.
Support
internal and external audits
and ensure timely audit responses.
Review batch records and ensure proper
batch release documentation
.
Coordinate with Production, QC, and other departments for quality compliance.
Handle
Regulatory Affairs activities
such as dossier preparation, submission, and follow-ups.
Ensure compliance with
WHO-GMP, Schedule M, and other applicable regulations
.
Maintain document control and ensure data integrity.
Requirements:
Experience in
QA & RA within a pharmaceutical company is mandatory
.
Strong knowledge of
GMP, QMS, documentation, and regulatory requirements
.
Good understanding of pharma manufacturing processes.
Ability to handle multiple tasks and meet timelines.
Good communication and coordination skills.
Job Types: Full-time, Permanent
Pay: Up to ₹180,000.00 per year
Benefits:
Cell phone reimbursement
Health insurance
Paid sick time
Provident Fund
Work Location: In person
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