Quality & Compliance Specialist - Homebased

• 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.

• Location Nationwide

• Reference SELECTHR-VACANCY-16001