Section Manager- Otsuka Pharma Japanese MNC, Ahmedabad

Role & responsibilities

• Monitoring of CMO operation
• Audit of CMO at periodic interval and Co-ordination with CMO site quality to ensure compliance
• Development QA checks for ongoing formulation development activites
• Qualification of RM/PM vendor Review and approval of specification and test procedure related to FSSAI product
• Review and approval of SOP related to FSSAI product Response to queries raised by MOH for FSSAI products
• Review and approval of finish product test reports and stabiliy data
• Complaint handling related to FSSAI products
• Batch release documents review and release of CMO products
• To prepare and review Deviation, Out of Specification and Change Control Note related to FSSAI products
• Any additional responsibilities assigned by HOD

Preferred candidate profile

Having hands on industrial experience w.r.t. QA system in Enteral Nutrition Industry.

Good understanding on FSSAI regulation Candidate has to interact with stakeholders, should
have good communication skills

Interested candidates can share their CV on Anee.Silas@otsukapharma.in