Senior Quality Specialist, Clinical

at  PCI Pharma Services

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.

Main Responsibilities:

• Compliance review of 3rd party batch documentation and preparation of batches for the QP. Review of the Product Spec File.
• Management of batch review and associated trackers, allocate batches on the tracker to each QA specialist.
• Raise Events, Deviations, Corrective and Preventative actions, Non-Conformance Reports as required and in a timely manner and ensure issues are escalated to management when needed.
• Liase with Project Managers and QA/QP Personnell to get urgent corrections completed in a timely manner.
• Generate and report on metrics to monitor compliance and effectiveness of the QMS for batch record review/ QP batch preparation.
• Provide quality assistance in investigation and resolution of internal and external quality issues applying risk management principles.
• Support regulatory inspections of the Millmount facility. Acting as SME for QA batch Review and preparation of documents for the QP.
• Support delivery of site/departmental projects and objectives.
• Promote a culture of zero overdues and proactively follow up with team members to ensure completion of actions within timelines.
• Support continuous improvement, activities.
• Author standard operating procedures.
• Provide QA and GMP related training.
• Provide Guidance to the Quality Specialists.
• Additional duties as required with job level

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 unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status

• Compliance review of 3rd party batch documentation and preparation of batches for the QP. Review of the Product Spec File.
• Management of batch review and associated trackers, allocate batches on the tracker to each QA specialist.
• Raise Events, Deviations, Corrective and Preventative actions, Non-Conformance Reports as required and in a timely manner and ensure issues are escalated to management when needed.
• Liase with Project Managers and QA/QP Personnell to get urgent corrections completed in a timely manner.
• Generate and report on metrics to monitor compliance and effectiveness of the QMS for batch record review/ QP batch preparation.
• Provide quality assistance in investigation and resolution of internal and external quality issues applying risk management principles.
• Support regulatory inspections of the Millmount facility. Acting as SME for QA batch Review and preparation of documents for the QP.
• Support delivery of site/departmental projects and objectives.
• Promote a culture of zero overdues and proactively follow up with team members to ensure completion of actions within timelines.
• Support continuous improvement, activities.
• Author standard operating procedures.
• Provide QA and GMP related training.
• Provide Guidance to the Quality Specialists.
• Additional duties as required with job leve