Audit & Compliance - Quality Assurance

Company : Unison Pharmaceuticals Pvt. Ltd

Experience : 8-15 Years

Location : Moraiya, Unit 3, Ahmedabad

Department : Quality Assurance

Role : Audit & Compliance

Roles & Responsibilities :

Audit

• Post audit triggering, arrangement of required documents from cross functional departments
• Collecting available documents from doc cell
• Shifting the documents received from departments and doc cell to war room before the audit.
• Ensure document traceability and retrieval during audit
• Supply the documents asked by auditors during the audit either from the documents available in war room or from respective department
• Explanation to auditor for quarry related to QMS and QA documentations

Post Audit

• Returning documents from war room to respective departments / doc cell post audit
• Preparing action plan based on the report received from auditor by coordination with cross functional teams
• Initiate CAPA with respect to action plan
• Follow-up and verification of actions taken
• Audit compliance report preparation which includes all responses against observations as well as respective attachments

CAPA Closure

• After completion of all actions mentioned in CAPA, cross verification and effectiveness checking of all actions
• Collection of all results from QC and preparation of hold time study report
• Intimate respective auditee as well as auditors based on the yearly schedule
• Provide audit checklist to auditors on the day of audit
• Collect audit report from auditors and get that approved by QA head
• Intimate respective auditee regarding audit observations and collect compliance report
• Verification and closure of observation post audit
• Adherence to the decided timelines of each activities as per SOPR

Interested candidates can share their Update CV on sandipnair@unisonpharmaceuticals.com