Section Manager (QA-EN)- Otsuka Pharma MNC, Ahmedabad

Job Description

Role & responsibilities Monitoring of CMO operation Audit of CMO at periodic interval and Co-ordination with CMO site quality to ensure compliance Oversee the QA department's activities to ensure adherence to industry standards and regulatory requirements for nutraceutical powder formulations. 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 QA system in Enteral Nutrition Industry. Good understanding on FSSAI regulation Candidate has to interact with stakeholders, should have good communication skills. Candidate should have experience in powder formulation from nutraceutical background or pharmaceutical industry . Interested candidates can share their Resume at Anee.Silas@otsukapharma.in