PDS QA Project Specialist
h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pAs 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. /p h31. RESPONSIBILITIES /h3 pReporting 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. /p pThe 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). /p h32. SPECIFIC DUTIES / KEY RESPONSIBILITIES /h3 h3Batch Review and Release /h3 ul liSupport 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. /li liEnsure proper filing and archiving of all batch record documentation in accordance with company standards and procedures. /li /ul h3Investigation Review /h3 ul liPerform preliminary assessments of deviations and customer complaints, assign an initial criticality classification, and evaluate whether escalation to management is required.
/li liReview investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs). /li liConduct comprehensive reviews of deviation and complaint investigations, including supporting documentation, quality impact assessments on affected batches and manufacturing areas, and regulatory and compliance implications. /li liContribute 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. /li liReview and approve Corrective and Preventive Actions (CAPAs) and the associated effectiveness verification records. /li /ul h3Customer Management and Inspections /h3 ul liParticipate in regular customer meetings and provide support via email, addressing quality-related inquiries within the assigned area of responsibility. /li liNotify customers of deviations and complaints in accordance with Quality Technical Agreements (QTAs) and ensure the timely closure of the corresponding records in TrackWise. /li liPrepare customer‑specific Key Performance Indicators (KPIs) and participate in on‑site customer visits. /li liActively participate in audit preparation activities. /li liSupport the presentation and discussion of relevant quality topics during audits. /li /ul h3Compliance /h3 ul liEnsure timely completion of all training activities assigned to the role. /li liEnsure 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. /li liReview Master Batch Records (MBRs)
for products associated with PDS projects, including clinical and commercial batches. /li liReview change controls related to PDS projects. /li liReview protocols and reports associated with clinical batches. /li liPrepare Product Specification Files (PSFs) for clinical batches in accordance with applicable SOPs and ensure they are continuously maintained and updated. /li liPrepare Risk Assessments related to PDS projects within the assigned area of responsibility. /li liReview Failure Mode and Effects Analyses (FMEAs) associated with PDS projects. /li /ul h33. WORKING RELATIONSHIPS /h3 h3Internal /h3 ul liManufacturing / Production /li liQA Compliance and Regulatory Affairs / Quality Control (QC) /li liBusiness Managers and Project Management Office (PMO) /li liTechnical Services /li liLogistics /li /ul h3External /h3 ul liCustomers /li liRegulatory Authorities /li /ul h34. REQUIREMENTS AND QUALIFICATIONS /h3 h3A. Essential Requirements /h3 h3Education / Qualifications / Training /h3 ul liBachelor's or Master's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology, or a related scientific discipline. /li /ul h3Technical Knowledge and Skills /h3 ul liKnowledge of pharmaceutical manufacturing processes and manufacturing controls for clinical and commercial products. /li liKnowledge of GMP requirements and FDA regulations. /li /ul h3Languages /h3 ul liEnglish. /li /ul h3Personal Skills and Competencies /h3 ul liStrong teamwork and collaboration skills. /li liExcellent organizational skills. /li liStrong interpersonal and communication skills. /li liEffective problem‑solving abilities. /li /ul h3B. Preferred Qualifications /h3 ul liDegree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Pharmacy. /li /ul pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr
/li liReview investigation plans and support investigators in identifying root causes and defining appropriate Corrective and Preventive Actions (CAPAs). /li liConduct comprehensive reviews of deviation and complaint investigations, including supporting documentation, quality impact assessments on affected batches and manufacturing areas, and regulatory and compliance implications. /li liContribute 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. /li liReview and approve Corrective and Preventive Actions (CAPAs) and the associated effectiveness verification records. /li /ul h3Customer Management and Inspections /h3 ul liParticipate in regular customer meetings and provide support via email, addressing quality-related inquiries within the assigned area of responsibility. /li liNotify customers of deviations and complaints in accordance with Quality Technical Agreements (QTAs) and ensure the timely closure of the corresponding records in TrackWise. /li liPrepare customer‑specific Key Performance Indicators (KPIs) and participate in on‑site customer visits. /li liActively participate in audit preparation activities. /li liSupport the presentation and discussion of relevant quality topics during audits. /li /ul h3Compliance /h3 ul liEnsure timely completion of all training activities assigned to the role. /li liEnsure 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. /li liReview Master Batch Records (MBRs)
for products associated with PDS projects, including clinical and commercial batches. /li liReview change controls related to PDS projects. /li liReview protocols and reports associated with clinical batches. /li liPrepare Product Specification Files (PSFs) for clinical batches in accordance with applicable SOPs and ensure they are continuously maintained and updated. /li liPrepare Risk Assessments related to PDS projects within the assigned area of responsibility. /li liReview Failure Mode and Effects Analyses (FMEAs) associated with PDS projects. /li /ul h33. WORKING RELATIONSHIPS /h3 h3Internal /h3 ul liManufacturing / Production /li liQA Compliance and Regulatory Affairs / Quality Control (QC) /li liBusiness Managers and Project Management Office (PMO) /li liTechnical Services /li liLogistics /li /ul h3External /h3 ul liCustomers /li liRegulatory Authorities /li /ul h34. REQUIREMENTS AND QUALIFICATIONS /h3 h3A. Essential Requirements /h3 h3Education / Qualifications / Training /h3 ul liBachelor's or Master's degree in Pharmaceutical Chemistry and Technology (CTF), Pharmacy, Chemistry, Biology, or a related scientific discipline. /li /ul h3Technical Knowledge and Skills /h3 ul liKnowledge of pharmaceutical manufacturing processes and manufacturing controls for clinical and commercial products. /li liKnowledge of GMP requirements and FDA regulations. /li /ul h3Languages /h3 ul liEnglish. /li /ul h3Personal Skills and Competencies /h3 ul liStrong teamwork and collaboration skills. /li liExcellent organizational skills. /li liStrong interpersonal and communication skills. /li liEffective problem‑solving abilities. /li /ul h3B. Preferred Qualifications /h3 ul liDegree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, or Pharmacy. /li /ul pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr