Audit & Compliance Manager – Sterile

Immacule Lifesciences; Solan; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading pharmaceutical company in India is seeking a Compliance Oversight professional to ensure adherence to all regulatory standards in sterile manufacturing. The role involves conducting internal audits, managing external inspections, and facilitating compliance training for staff. Candidates should have a strong background in quality assurance with 8–12 years of experience in compliance roles, including relevant degree and demonstrated hands-on experience in regulatory inspections. This position aims to reinforce a culture of compliance and ensure operational readiness.

Qualifications

• 8–12+ years of experience in Quality, Compliance, or Audit roles within sterile pharmaceutical manufacturing.
• Proven experience leading regulatory inspections (FDA, EMA, MHRA) and customer audits.
• Hands-on experience with internal audits, CAPA management, and inspection readiness.

Responsibilities

• Ensure site-wide compliance with all applicable regulations for sterile manufacturing.
• Plan, lead, and execute internal audits to assess compliance with SOPs and regulatory requirements.
• Manage and coordinate audits and inspections conducted by regulatory authorities.
• Conduct regular compliance walk-throughs to assess facility conditions.
• Identify potential compliance risks and implement risk mitigation strategies.

Skills

Knowledge of cGMP regulations

Strong compliance oversight

Audit management

Risk management

Education

Bachelor’s or Master’s degree in Pharmacy

Job description

Compliance Oversight

• 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.