Advert Text
Job Role - Quality & Compliance Specialist
Location - Homebased
Excellent Company Benefits
Overall Purpose of the Job
The Quality & Compliance Specialist will support day-to-day quality assurance, compliance oversight, and documentation control activities for a dedicated pharmaceutical client contract. This role ensures all deliverables meet regulatory standards (e.g., GMP, GDP, GCP), contractual obligations, and internal quality management system (QMS) requirements. The position acts as a key liaison between the client, internal teams, and regulatory expectations, ensuring that quality and compliance are proactively maintained throughout the contract lifecycle.
Main Duties and Responsibilities:
Quality Oversight & Compliance
- Ensure all client-related activities are conducted in accordance with applicable regulatory guidelines (FDA, EMA, MHRA, ICH, etc.) and internal QMS.
- Monitor compliance with contractual quality requirements, SOPs, and quality agreements.
- Conduct quality reviews of deliverables, reports, and documentation before client submission.
- Maintain awareness of changes in relevant regulations and ensure processes remain compliant.
Documentation & Record Management
- Review, approve, and maintain controlled documents (SOPs, work instructions, protocols, reports).
- Ensure timely and accurate documentation of deviations, CAPAs, and change controls.
- Maintain contract-specific quality files and audit trails.
Audits & Inspections
- Support internal audits, client audits, and regulatory inspections.
- Coordinate audit responses, track findings, and verify closure of corrective actions.
- Participate (if applicable) in supplier qualification and oversight activities related to the contract.
Training & Support
- Deliver or coordinate quality and compliance training for project and operational teams.
- Provide day-to-day guidance to internal and client-facing teams on quality expectations.
- Support the creation and continuous improvement of quality metrics and dashboards for client reporting.
Risk Management & Continuous Improvement
- Identify quality risks and work with stakeholders to develop mitigation strategies.
- Recommend and implement process improvements that enhance compliance and efficiency.
- Support root cause analysis for deviations or nonconformances.
Person Specification
- High attention to detail and accuracy.
- Integrity and strong ethical standards.
- Proactive approach to identifying and mitigating risks.
- Ability to work independently and collaboratively.
- Strong communication and interpersonal skills, with the ability to influence and engage at all levels.
- Analytical mindset with excellent problem-solving and decision-making abilities.
- Thrives in dynamic contract environments with evolving client needs.
Qualifications & Experience:
Essential:
- Bachelor’s degree in quality management, Compliance, Business Administration, or related field.
- Proven experience in a quality, compliance, or audit role (minimum 3 years).
- Strong knowledge of relevant regulatory frameworks and quality standards.
- Strong understanding of GxP regulations (GMP/GDP) and international guidelines.
- Experience working with clients or in a contract/service provider environment.
- Excellent attention to detail, organizational skills, and problem-solving abilities.
Desirable:
- Professional certification such as ISO Lead Auditor, CQI, or similar.
- Experience in industry-specific compliance, e.g., healthcare, manufacturing.
- Proficiency with QMS software and data analysis tools.