Posted:2 weeks ago|
Platform:
Work from Office
Full Time
1) Handling of Quality management system.
2) Monitoring Process validation program.
3) Handling of customer and regulatory audits.
4) Monitoring Equipment Qualification program.
5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies.
6) Conducting internal audits as per schedule.
7) CAPA effectiveness verification.
8) Conducting Quality review board meetings and management review meetings as per schedule.
9) Monitoring Equipment cleaning program.
10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC supporting documentation.
11) Reviewing the Quality Agreement and Technical Agreement for the site.
12) Handling of Quality system and perform risk assessment to the required quality system.
13) Preparation and review of Comprehensive assessment report of Quality Management Systems.
14) Review of Annual product review (APR) reports.
15) Providing training on cGMP topics to all employees at site.
16) Review and approving site SOPs.
17) GxP related qualification, investigation and monitoring.
18) Periodic Review of electronic systems and ensuring the compliance.
19) Review and guidance to team on regular operation challenges.
20) Any other activities assigned by HOD.
Experience: 15-20 years in QA
SAI Life Sciences
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