Ensure compliance to regulatory requirements on product, process, equipment and release procedures.
Manage Batch certification activities related to commercial dispatch in a timely manner.
Escalate compliance concern to concern stakeholder.
Review, compliance of BPR and batch release for commercial dispatch.
Review and approve all deviations and OOS/OOT investigations
Execute change control and risk assessment whenever required.
Ensure Quality Metrics are reported as per specify timeline.
Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures.
Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements.
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