Regulatory and compliance liaison expert- vaccine

4 weeks ago

Shimla, India Panacea Biotec Full time

Job Title: Regulatory & Compliance Liaison (RCL) - VDSP, Lalru & VDPP, BaddiReports To: COO – VaccineDepartment: COO – VaccineLocation: Baddi, Himachal PradeshRole Summary:The Regulatory & Compliance Liaison (RCL) will support the COO- Vaccine in maintaining the plant's global and domestic compliance status. This role is key to ensure operational alignment for regulatory expectations, inspections and compliance strategy for readiness of audits by WHO, national regulatory bodies, and other international agencies. The RCL will coordinate audit schedules, track critical compliance activities, and ensure effective cross-functional alignment.Key Responsibilities:Audit and Inspection Calendar ManagementMaintains and updates a comprehensive calendar of internal audits, vendor inspections, and regulatory audits to ensure proactive preparedness across departments. Site wide coordination for inspections, compliance monitoring and regulatory interface affecting daily operations and manage inspection logistics.CAPA and Observation TrackingMonitors and tracks Corrective and Preventive Actions (CAPAs), major audit/inspection observations, and facilitates timely closure in line with expectations.Data Integrity and Computer System Validation (CSV)Supports and tracks implementation of data integrity initiatives and computer system validation projects in accordance with ALCOA++ principles and global standards.Compliance Communication & AlignmentCollaborates with Quality Assurance (QA) and Regulatory Affairs (RA) to ensure consistent communication and implementation of compliance updates.Qualifications & Experience:Bachelor’s or Master’s degree in Biotechnology, Pharmacy, Life Sciences, or a related field8–12 years of experience in regulatory audits & compliance in Biological /vaccine industry , preferably in a WHO-prequalified or globally regulated manufacturing facilityStrong understanding of c GMP, data integrity, CSV, regulatory audit processes & regulatory guidelines/expectations.Excellent organizational and cross-functional coordination skillsKey Skills & Competencies:Strong knowledge of c GMP, WHO, and global regulatory compliance standardsExperience in managing audit calendars and ensuring inspection readinessProficiency in CAPA tracking and closure of audit/inspection observationsFamiliarity with Computer System Validation (CSV)Effective coordination with cross-functional teams including QA, RA, and ITExcellent documentation, reporting, and compliance communication skillsHigh attention to detail and a proactive approach to maintaining compliance

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