PDS QA Project Specialist

Location: Monza, Monza e Brianza, Italy

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

1. RESPONSIBILITIES

Reporting to the relevant QA Operations Team Leader, the PDS QA Project Specialist supports the Qualified Person (QP) in assessing manufactured batches and the manufacturing environment by reviewing Certificates of Analysis (CoAs) and other relevant documentation.

The role is responsible for performing preliminary impact assessments of deviation events, reviewing investigation reports, collecting customer complaints, and reviewing the related investigations, ensuring compliance with applicable standards, company procedures, and regulatory requirements (including GMP, FDA regulations, and other applicable legislation).

2. SPECIFIC DUTIES / KEY RESPONSIBILITIES

Batch Review and Release

• Support the Qualified Person (QP) and the Quality Operations Manager in the batch release process, ensuring compliance with product specifications through the review of Certificates of Analysis, collection and assessment of executed Batch Manufacturing Records, and verification of the status of deviations and change controls associated with each batch.
• Ensure proper filing and archiving of all batch record documentation in accordance with company standards and procedures.

Investigation Review

• Perform preliminary assessments of deviations and customer complaints, assign an initial criticality classification, and evaluate whether escalation to management is required.
• Review investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs).
• Conduct comprehensive reviews of deviation and complaint investigations, including supporting documentation, quality impact assessments on affected batches and manufacturing areas, and regulatory and compliance implications.
• Contribute to achieving Zero Past Due targets within the assigned area of responsibility, as well as Right First Time (RFT) and On-Time Delivery (OTD) objectives.
• Review and approve Corrective and Preventive Actions (CAPAs) and the associated effectiveness verification records.

Customer Management and Inspections

• Participate in regular customer meetings and provide support via email, addressing quality-related inquiries within the assigned area of responsibility.
• Notify customers of deviations and complaints in accordance with Quality Technical Agreements (QTAs) and ensure the timely closure of the corresponding records in TrackWise.
• Prepare customer-specific Key Performance Indicators (KPIs) and participate in on-site customer visits.
• Actively participate in audit preparation activities.
• Support the presentation and discussion of relevant quality topics during audits.

Compliance

• Ensure timely completion of all training activities assigned to the role.
• Ensure that Standard Operating Procedures (SOPs) relevant to the assigned area of responsibility are continuously updated by preparing and maintaining the required documentation in compliance with current GMP requirements.
• Review Master Batch Records (MBRs) for products associated with PDS projects, including clinical and commercial batches.
• Review change controls related to PDS projects.
• Review protocols and reports associated with clinical batches.
• Prepare Product Specification Files (PSFs) for clinical batches in accordance with applicable SOPs and ensure they are continuously maintained and updated.
• Prepare Risk Assessments related to PDS projects within the assigned area of responsibility.
• Review Failure Mode and Effects Analyses (FMEAs) associated with PDS projects.

3. WORKING RELATIONSHIPS

Internal

• Manufacturing / Production
• QA Compliance and Regulatory Affairs / Quality Control (QC)
• Business Managers and Project Management Office (PMO)
• Technical Services
• Logistics

External

• Customers
• Regulatory Authorities

4. REQUIREMENTS AND QUALIFICATIONS

A. Essential Requirements

Education / Qualifications / Training

• Bachelor's or Master's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology, or a related scientific discipline.

Technical Knowledge and Skills

• Knowledge of pharmaceutical manufacturing processes and manufacturing controls for clinical and commercial products.
• Knowledge of GMP requirements and FDA regulations.

Languages

• English.

Personal Skills and Competencies

• Strong teamwork and collaboration skills.
• Excellent organizational skills.
• Strong interpersonal and communication skills.
• Effective problem-solving abilities.

B. Preferred Qualifications

• Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Pharmacy.