Life-changing therapies.
Global impact.
Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in people who make an impact, drive progress, and create a better tomorrow.
Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Description
Position:
Qualified Person (Hybrid – 3rd Party Products)
Department:
Quality Division / Clinical Services
Accountable to:
Associate Director of Quality
Accountable for:
People Manager, including managerial support to QA specialists
Responsibilities
Overall Quality Responsibilities
Certify investigational medicinal products according to IMPD and PSF requirements.
Ensure all batches comply with EU Directives, Annex 16, and relevant guidelines for IMPs.
Support and guide the Quality management team to meet safety, quality, and cGMP requirements.
Participate in cross-functional teams on quality issues.
Maintain programs to ensure high-quality products and compliance with GMP and GCP standards.
Review and ensure regulatory compliance during importation, testing, and release of clinical products.
Complete QP declarations and review/dispose of Drug Substance, Drug Product, and Finished Pack for various dosage forms.
Quality Operations
Review batch documentation for compliance and audit standards.
Review clinical batch records and release reports.
Distribute and certify batches efficiently.
Monitor quality standards and implement corrective actions.
Quality Systems
Support investigations and resolve discrepancies.
Lead or recommend CAPAs.
Assist with change control assessments.
Communicate with contract manufacturers to resolve compliance issues.
Support audits and address observations.
Assist with customer complaints and deviations.
Quality Projects & Continuous Improvement
Support QA team development and process improvements.
Develop and update technical agreements.
Assist with new product introductions.
Promote best practices and continuous improvement methodologies.
Develop and support training programs.
General
Collaborate across the organization and represent QA in meetings.
Stay updated on pharmaceutical legislation and industry practices.
Apply knowledge of EU regulations and industry standards in daily activities.
Secondary Responsibilities
Supervise QA specialists and review batch records.
Perform additional tasks as required.
Requirements
Bachelor's degree in science, engineering, or related field.
Qualified Person status or eligibility.
3-5 years' experience in pharma quality management.
Knowledge of EU GMP, sterile experience preferred.
Strong organizational, leadership, and decision-making skills.
Experience in management roles within similar environments.
Motivated, flexible, and able to work under pressure.
Join us and be part of building the bridge between life-changing therapies and patients.
Let's talk future.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
We do not discriminate based on race, color, religion, age, sex, creed, national origin, and other protected statuses.
At PCI, Equity and Inclusion are core to our purpose: delivering life-changing therapies.
We are committed to an inclusive workplace where everyone can belong and grow.
About Us
Why work for PCI Pharma Services?
We focus on quality, operational excellence, and customer experience.
Our people make this happen, and we aim to create a fulfilling environment for career growth.
We value learning, real-life experience, and a fair rewards program.
Our approach is simple: our people fuel our business; we don't say no, we find solutions.
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