Immacule Lifesciences
Website:
immacule.in
Job details:
Regulatory Compliance
- Ensure site-wide compliance with all applicable regulations, including cGMP, FDA, EMA, MHRA, and other global regulatory standards for sterile manufacturing.
- Maintain up-to-date knowledge of regulatory changes, guidance documents, and industry trends to ensure ongoing compliance.
- Act as the site subject matter expert for audit and compliance-related matters.
Audit Management
- Plan, lead, and execute internal audits to assess compliance with SOPs, quality systems, and regulatory requirements.
- Develop and maintain an annual audit program covering all operational, manufacturing, laboratory, engineering, and quality systems.
- Introduce and conduct random, unannounced audits focusing on critical areas such as aseptic practices, cleanliness, documentation, data integrity, and critical equipment.
- Perform real-time reviews of batch records, validation protocols, and production practices to ensure compliance.
External Audits & Inspections
- Manage and coordinate audits and inspections conducted by regulatory authorities, customers, and third-party auditors.
- Prepare the site for regulatory and customer audits, including readiness assessments, mock inspections, and staff training.
- Lead responses to audit observations and inspection findings, including regulatory commitments.
- Track, manage, and ensure timely closure of audit observations, CAPAs, and effectiveness checks.
Compliance Monitoring & Walk-Throughs
- Conduct regular and unscheduled compliance walk-throughs to assess facility conditions, aseptic behaviors, documentation practices, and safety compliance.
- Use walk-throughs as an opportunity to engage with site personnel and reinforce a culture of compliance and quality ownership.
Risk Management & Continuous Improvement
- Identify potential quality and compliance risks and implement appropriate risk mitigation strategies.
- Drive continuous improvement initiatives to enhance compliance, reduce deviations, and improve overall quality performance.
- Lead initiatives to streamline processes and strengthen inspection readiness in sterile manufacturing operations.
Cross-Functional Collaboration & Communication
- Collaborate closely with Manufacturing, Engineering, R&D, Quality Control, Procurement, and Supply Chain to ensure compliance expectations are understood and upheld.
- Serve as the primary liaison between the site and corporate headquarters for all audit and compliance-related activities.
- Act as the point of contact for compliance issues within the plant and lead compliance-related meetings.
Reporting & Stakeholder Management
- Provide regular compliance status reports, audit metrics, and risk assessments to senior management.
- Communicate effectively with customers and external stakeholders regarding compliance-related topics, audits, and updates.
Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, or a related field.
- 8–12+ years of experience in Quality, Compliance, or Audit roles within sterile pharmaceutical manufacturing.
- Strong knowledge of cGMP regulations and regulatory expectations for aseptic processing.
- Proven experience leading regulatory inspections (FDA, EMA, MHRA) and customer audits.
- Hands-on experience with internal audits, CAPA management, and inspection readiness.
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