Quality Assurance Specialist 3rd Party Products

2 weeks ago

The Municipal District of Dundalk, Ireland PCI Pharma Services Full time
Quality Assurance Specialist 3rd Party Products

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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.

Summary Of Role

This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.

  • Part of the Batch File Review Team who: Compile batch documents

Review batch documents in advance of QP review

Work with responsible site to complete corrections

Prepare COC for QP

Work closely with QP as issues arise and find resolution
  • Perform a batch file review for batches manufactured/packed at PCI or in third party company.
  • Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
  • Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
  • Coordination of every product supply chain flow – products which are coming from rest of the world and releasing to the European Union
  • Participating customer meetings – discussion/collection/summary about the necessary quality documentation
  • Writing SOPs or Work Instructions
  • Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
  • Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
  • Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential

Knowledge / Skills & Experience
  • Degree and/or relevant experience.
  • GMP experience
  • Steriles Experience
  • Good communication skills.
  • Ability to problem solve.
  • Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
  • Minimum 2 yrs years' experience working in Quality Assurance
  • Proven track record of showing how results were delivered through management/leadership of others.
  • Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.

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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionQuality Assurance
  • IndustriesPharmaceutical Manufacturing

Referrals increase your chances of interviewing at PCI Pharma Services by 2x

Banbridge, Northern Ireland, United Kingdom 1 day ago

Newry, Northern Ireland, United Kingdom 3 weeks ago

Banbridge, Northern Ireland, United Kingdom 2 weeks ago

Banbridge, Northern Ireland, United Kingdom 2 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

  • Quality Assurance Specialist 3rd Party Products

    2 weeks ago

    The Municipal District of Ashbourne, Ireland PCI Pharma Services Full time

    Quality Assurance Specialist 3rd Party Products2 days ago Be among the first 25 applicantsLife 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...

  • Third-Party Product Quality Assurance Specialist

    2 weeks ago

    The Municipal District of Dundalk, Ireland beBeeQualityAssurance Full time €40,000 - €55,000

    As a Quality Assurance Specialist, you will be responsible for ensuring the quality of products manufactured by third-party companies.This role offers an exciting opportunity to work in a dynamic environment with multiple stakeholders across various departments.Compile and review batch documents prior to QP review.Collaborate with responsible sites to...

  • Quality Assurance Specialist

    2 weeks ago

    The Municipal District of Muinebeag, Ireland TPx Full time

    Quality Assurance Specialist (Ireland Remote)Join to apply for the Quality Assurance Specialist (Ireland Remote) role at TPxQuality Assurance Specialist (Ireland Remote)Join to apply for the Quality Assurance Specialist (Ireland Remote) role at TPxGeneral Purpose:We are seeking a skilled Quality Assurance Specialist to join our technology team. The ideal...

  • Quality Assurance Specialist

    2 weeks ago

    Municipal District of Cobh, Ireland beBeeQuality Full time €70,000 - €90,000

    Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Job Description:The Quality Assurance Specialist will be responsible for implementing and maintaining...

  • Quality Assurance Specialist

    2 weeks ago

    The Municipal District of Muinebeag, Ireland TPx Full time

    General Purpose:We are seeking a skilled Quality Assurance Specialist to join our technology team. The ideal candidate will have 3+ years of experience in software quality assurance or a similar role, with the ability to ensure the functionality, security, performance, and usability of our applications. Experience testing SaaS platforms such as ServiceNow or...

  • QA Warehouse Specialist

    3 weeks ago

    The Municipal District of Ashbourne, Ireland PCI Pharma Services Full time

    3 days ago Be among the first 25 applicantsLife 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.We are...

  • Production Associate-3rd Shift

    3 weeks ago

    Kenmare Municipal District, Ireland Sonoco Full time

    Join to apply for the Production Associate-3rd Shift role at Sonoco3 days ago Be among the first 25 applicantsJoin to apply for the Production Associate-3rd Shift role at SonocoLocation: Hillview, KYPosition: Production AssociateAvailable Shift: 3rd ShiftPay: $18.34+ $2.00 Shift DifferentialFrom a small family business to a multi-billion dollar global...

  • Product Supply Chain Coordinator

    2 weeks ago

    The Municipal District of Ashbourne, Ireland beBeeQualityAssurance Full time €58,000 - €82,000

    Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our Batch File Review Team.Compile batch documents and review them in advance of QP review, ensuring accuracy and timeliness.Collaborate with responsible sites to complete corrections and prepare COC for QP, maintaining effective communication channels.Perform batch...

  • Quality Assurance Engineer

    2 weeks ago

    The Municipal District of Muinebeag, Ireland TPx Full time

    Quality Assurance Engineer (Ireland Remote)Join to apply for the Quality Assurance Engineer (Ireland Remote) role at TPxQuality Assurance Engineer (Ireland Remote)Join to apply for the Quality Assurance Engineer (Ireland Remote) role at TPxGeneral Purpose:We are seeking a QA Engineer to design, develop, and maintain a Selenium-based test automation framework...

  • Software Test Assurance Expert

    2 weeks ago

    The Municipal District of Muinebeag, Ireland beBeeQuality Full time €60,000 - €80,000

    Quality Assurance ProfessionalWe are seeking a skilled Quality Assurance Specialist to join our technology team. The ideal candidate will have 3+ years of experience in software quality assurance or a similar role, with the ability to ensure the functionality, security, performance, and usability of our applications.Experience testing SaaS platforms such as...