REGULATORY AND COMPLIANCE LIAISON EXPERT- VACCINE (DS&DP MANUFACTURING PLANT)

Job Title: Regulatory & Compliance Liaison (RCL) - VDSP, Lalru & VDPP, Baddi

Reports To: COO – Vaccine

Department: COO – Vaccine

Location: Baddi, Himachal Pradesh

Role 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 Management

Maintains 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 Tracking

Monitors 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 & Alignment

Collaborates 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 field
• 8–12 years of experience in regulatory audits & compliance in Biological /vaccine industry , preferably in a WHO-prequalified or globally regulated manufacturing facility
• Strong understanding of cGMP, data integrity, CSV, regulatory audit processes & regulatory guidelines/expectations.
• Excellent organizational and cross-functional coordination skills

Key Skills & Competencies:

• Strong knowledge of cGMP, WHO, and global regulatory compliance standards
• Experience in managing audit calendars and ensuring inspection readiness
• Proficiency in CAPA tracking and closure of audit/inspection observations
• Familiarity with Computer System Validation (CSV)
• Effective coordination with cross-functional teams including QA, RA, and IT
• Excellent documentation, reporting, and compliance communication skills
• High attention to detail and a proactive approach to maintaining compliance