Compliance Specialist
PCI Pharma Services
Summary
As the Engineering Compliance Specialist, you will play a pivotal role in ensuring the effective management and implementation of change controls, deviations, CAPA plans, and SOP updates within our sterile fill finish operations. You will collaborate with various departments to drive continuous improvement, maintain regulatory compliance, and enhance overall operational efficiency.
Job description
Change Control Management
- Initiate, review, and manage change control documentation related to equipment, processes, and systems.
- Facilitate cross-functional communication to ensure alignment with stakeholders and timely resolution of change requests.
- Conduct impact assessments to evaluate the potential effects of proposed changes on product quality, safety, and efficacy.
Deviation Handling
- Lead investigations into deviations, identifying root causes and implementing corrective and preventive actions.
- Collaborate with Quality Assurance, Manufacturing, and other relevant departments to develop comprehensive deviation reports.
- Ensure timely closure of deviations while maintaining compliance with regulatory requirements.
CAPA (Corrective and Preventive Action) Planning
- Develop and execute robust CAPA plans in response to identified issues or areas for improvement.
- Coordinate with cross-functional teams to implement corrective actions and preventive measures.
- Monitor and track CAPA effectiveness, making adjustments as necessary to enhance long-term performance.
Communication and Collaboration
- Act as a liaison between engineering, quality, manufacturing, and other relevant departments to ensure seamless communication and collaboration.
- Provide regular updates on change control, deviations, and CAPA status to management and relevant stakeholders.
- Foster a culture of proactive problem-solving and continuous improvement.
Requirements
- 2+ years' experience with GMP, ISO, and/or an FDA-regulated environment
- Strong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, SOPs, Reports, etc.)
- SME in investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment
- Strong understanding of regulatory requirements and industry best practices
- Bachelor's Degree in a Science or Engineering related field preferred
- Detail oriented with strong analytical and problem-solving capabilities
- Project management skills and the ability to drive initiatives to completion
- Excellent communication and interpersonal skills with the ability to work collaboratively across departments
- Assertive, self-directed, and results-oriented
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.