Compliance Specialist

Role Overview

The Compliance Specialist plays a central role in keeping quality systems and manufacturing operations aligned with regulatory expectations and internal standards. On a daily basis, this person reviews change controls, tracks corrective and preventive actions, coordinates internal audits, and supports risk assessments and training programs. Their work directly strengthens inspection readiness and builds a proactive compliance culture across the site.

Key Responsibilities

• Assess change control requests for their impact on product quality, and confirm that all modifications are implemented in accordance with regulatory requirements and company policies.
• Manage the CAPA process by monitoring action items, ensuring timely closure with adequate supporting evidence, and verifying that effectiveness checks are completed.
• Coordinate the site’s internal audit program, track audit findings, and drive timely completion of corrective actions according to the annual audit schedule.
• Facilitate risk assessments across quality systems and manufacturing operations, ensuring alignment with ICH, ISO, and applicable regulatory frameworks.
• Support the site training program by monitoring monthly completion rates and ensuring all personnel meet required training deadlines.
• Assist with preparing for regulatory inspections and conducting audit readiness assessments.
• Coordinate the site’s problem-solving initiatives, helping teams identify root causes and implement sustainable solutions.
• Provide oversight for product lifecycle management activities, including specification updates and change tracking.
• Compile and report monthly key performance indicators (KPIs) related to site compliance activities.
• Serve as a backup for the Quality Systems & Compliance Lead and the Data Integrity Lead when needed. Some responsibilities may be delegated to the Data Integrity Lead, provided appropriate training and competence are maintained.

Requirements & Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, Biochemistry, or a related social or physical science.
• 3–5 years of experience in a pharmaceutical or consumer healthcare manufacturing environment, with direct exposure to GMP compliance activities.
• Strong knowledge of GMP, quality systems, and regulatory compliance requirements.
• Previous experience in an analytical laboratory or production setting is preferred.
• Excellent analytical, interpersonal, and facilitation skills.
• Ability to influence without direct authority and communicate effectively across all levels of the organisation to drive change.
• Analytical mindset with strong attention to detail and accuracy in documentation.
• Well-developed organisational, planning, and prioritisation abilities.
• Good verbal and written communication skills.
• Result-oriented approach to work.
• High level of integrity, accountability, and commitment to fostering a quality-driven culture.
• Ability to balance regulatory compliance with business objectives while mitigating risks.