Compliance Specialist

LotusWorks is an Engineering Services provider specializing in managing Commissioning, Construction Services, Calibration, Operations & Maintenance scopes of work within global manufacturing facilities. LotusWorks operates globally across EMEA and North America partnering with the world's leading manufacturers across the Semiconductor, Pharmaceutical & Biologics, Medical Device and Data Centre sectors. Our team of Engineering and Technical professionals is immersed in cutting-edge technologies and innovations. LotusWorks is committed to a diverse and inclusive workplace, integral to our people-first approach. 

The Compliance Specialist is responsible for supporting and maintaining compliance with Good Manufacturing Practice (GMP) regulations and internal quality systems across the Utilities & Facilities operations. This role works closely with internal stakeholders and external vendors to ensure Employees and Master Service Agreement (MSA) contractors meet company, regulatory, and industry standards. The successful candidate will coordinate reporting, documentation, and performance tracking activities to ensure safe, high-quality, and cost-effective service delivery. The Compliance Coordinator will work cross-functionally to promote a culture of compliance and regulatory adherence.

Responsibilities:

As a Compliance Specialist your job responsibilities will include:

1. Safety

• Coordinate to ensure all contractual requirements and vendor/contractor engagements meet or exceed company and industry safety standards.


• Actively support and enforce Environmental, Health, Safety, and (EHS) compliance across Utilities & Facilities activities.


• Monitor MSA vendors’ and Engineering teams’ safety performance, collaborating with Engineering and EHS teams to address risks, incidents, and corrective actions.


• Coordinate safety reporting, documentation, and data collection to maintain compliance records and performance tracking.

2. Quality

• Monitor compliance with GMP regulations and company SOPs.


• Support maintenance of the Quality Management System (QMS).


• Assist in implementation and tracking of corrective and preventive actions (CAPA).


• Participate in internal audits and self-inspections.


• Support contractual compliance with agreed scopes of work, technical specifications, and service-level expectations.


• Ensure proper documentation practices in accordance with GMP guidelines.


• Maintain document control systems and ensure timely updates of SOPs.


• Coordinate with Quality Assurance teams to ensure vendor services meet organizational quality benchmarks.


• Implement and track corrective actions when vendor performance or deliverables fall below agreed standards.


• Conduct document reviews and ensure compliance with established quality standards and on-site procedures.


• Support deviation investigations and root cause analysis.

3. People

• Foster strong working relationships with internal stakeholders including Engineering, Operations, Quality, Procurement, Legal, and Safety teams.


• Engage and coordinate with external service providers to ensure mutual understanding of contractual expectations and promote a collaborative work environment.


• Support team development through knowledge sharing, mentoring, and continuous improvement initiatives related to contract and compliance management.

4. Delivery

• Assist and support the department with regulatory inspections and audits by agencies


• Prepare compliance reports and audit documentation.


• Ensuring monitoring and tracking of regulatory commitments and ensure timely responses to findings.


• Support timely execution of contractual deliverables and proactively resolve schedule variances through coordination with MSA vendors and internal teams.


• Track vendor service timelines, milestones, and key performance indicators to ensure obligations are met within agreed timeframes.


• Facilitate regular vendor performance reviews and status update meetings with key stakeholders.


• Coordinate compliance training programs for employees.


• Maintain training records and ensure compliance with regulatory requirements.


• Promote continuous quality improvement initiatives.


• Identify compliance risks and support mitigation plans.


• Contribute to process improvements to strengthen regulatory compliance.

5. Cost

• Monitor and manage contract purchase orders to ensure alignment with budgetary constraints and financial targets.


• Review and validate vendor invoices against contractual terms, ensuring billing accuracy and proper cost allocation.


• Identify opportunities for cost savings and operational efficiencies through effective contract oversight and vendor performance management.


• Any other duties or responsibilities that may be assigned to you in your role.   

Skills Required:

• 2–5 years’ experience in contract administration, compliance coordination, vendor management, project coordination, or facilities/engineering support in a GMP-regulated environment (pharmaceutical, biotech, medical device, or related industry) desirable.


• Working knowledge/ appreciation of EHS and quality management systems, desirable.


• Experience of reviewing contracts, purchase orders, and invoices or an understanding of the same.


• Strong organizational skills with high attention to detail.


• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and document management systems.


• Excellent communication and stakeholder engagement skills.


• Experience with regulatory inspections and audit preparation preferred.


• Strong analytical and problem-solving abilities.


• Understanding/ awareness of GMP regulations and quality systems.


• Excellent documentation and organizational skills.


• Effective coordination and time management skills


• Ability to manage multiple priorities in a fast-paced environment


• Collaborative and relationship-driven approach


• Effective communication and cross-functional collaboration skills.


• Proficiency in MS Office and quality management software systems.


• High level of integrity and accountability.

Education / Licenses / Certifications:

• Diploma or Degree in Business Administration, Engineering, Compliance, Quality Management, Project Management, or a related field.


• Proof of education, licenses, and certifications will be required where applicable.

Benefits:

• VHI Healthcare Cover


• Life Assurance


• Pension Contribution


• Training And Educational Assistance


• Annual GP Check-Up


• Extra Annual Leave


• Healthcare Screening


• Recognition Rewards

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