Compliance Specialist

About the role

• The responsibility of the Compliance Specialist is to support compliance activities in Auditing, Inspection Readiness, Change Control, CAPA management, Risk Management, Training & PLM oversight.

Key responsibilities

• Review and assess change controls for quality impact and ensure changes are implemented in compliance with regulatory and Haleon standards.
• Coordinate CAPA management through oversight of timely CAPA closures ensuring adequate supporting evidence is provided, and effectiveness checks are undertaken.
• Coordinate the site internal audit program and ensure timely monitoring and closure of audits as per the annual audit schedule.
• Support risk assessments across quality systems and operations aligned with HQS, regulatory requirements, ICH and ISO standards.
• Support site training program and ensure timely monitoring and completion of monthly training requirements for the site.
• Support in audit readiness assessments and preparations.
• Coordinate site problem solving program.
• Oversight product lifecycle management activities including specification updates and change tracking.
• Monitor and update monthly KPI status for site compliance activities.
• Stand in as a backup for Quality Systems & Compliance Lead and Data Integrity Lead.
• Responsibilities of the role can be delegated to the Data Integrity Lead supported by appropriate training and competence.

 Qualifications and skills

Essential

• Bachelor’s degree in chemistry, Pharmacy, Microbiology, Chemical Engineering, Biochemistry, Social or Physical Sciences
• 3-5 years in a pharmaceutical or consumer healthcare manufacturing environment with direct exposure to GMP compliance activities

Preferred

• Strong knowledge of GMP, quality systems and regulatory compliance requirements.
• Previous experience working in an analytical lab or production.
• Excellent analytical and interpersonal and facilitation skills
• Ability to influence without authority and communicate to all levels of team structure to enable and drive change.
• Analytical mindset with attention to detail and accuracy in documentation.
• Organizational, planning and prioritization skills.
• Good verbal and written communication skills.
• Result-oriented.
• High level of integrity, accountability and commitment to fostering a quality-driven culture.
• Ability to balance regulatory compliance with business objectives while mitigating risks.