Regulatory QC Specialist

3 weeks ago

Cork, Cork, Ireland Life Science Recruitment Full time

Reg Affairs / Compliance QC Specialist

This is an opportunity for a skilled QC Specialist to join our team at a leading manufacturer and distributor of X-ray and MRI Contrast Media. As part of the Pharmaceutical Diagnostics (PDx) business, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time.

Main Responsibilities
  • Management of pharmacopoeia reviews and resulting procedural changes.
  • QC representative for Regulatory assessments.
  • QC support for method transfer.
  • Support method validation activities, through writing and executing protocols.
  • Complete review/approval of validation documentation for other team members on request.
  • Provide leadership, coaching and mentoring for QC Specialist Team.
Compliance
  • System documentation, including SOPs, protocols, Validation lifecycle/CSV documentation.
  • Ownership of quality systems actions (IR's, CAPA, CC) ensuring timely closure and performance trending.
  • Act as a technical and compliance liaison between QC Functional team and Operations / Engineering / QA.
  • Participation in internal and external audits and active follow up on audit items.
  • Identifying productivity and compliance opportunities and driving same to completion.
Qualifications and Experience
  • Level 8 degree in Chemistry / Microbiology, or in a Science/Engineering subject.
  • Familiar with Regulatory and ICH expectations of good laboratory practices, equipment qualification and maintenance.
  • Familiar with QC systems and processes, especially LIMS, MODA & Veeva.
  • Experienced in data compilation, review and report generation.
  • Experienced in Data Integrity requirements for QC.
  • Project Management - leading & oversight as well as contributory role.
Skills Required:
  • Highly attentive to detail.
  • Self-motivated, goal driven person.
  • Experienced in technical problem solving.
  • Good organisational skills.
  • Strong ability to perform, challenge and positively influence in an interactive team environment.

We are a 24/7 operation exporting to 93 markets worldwide and employ approximately 600 staff at our campus in Co. Cork.

  • Regulatory QC Specialist

    3 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Reg Affairs/Compliance QC SpecialistThis is an opportunity for a skilled QC Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.Main Responsibilities:Management of pharmacopoeia reviews and resulting procedural changes.QC representative for regulatory assessments.QC support for method...

  • Regulatory QC Specialist

    4 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    Reg affairs / Compliance QC specialist Description My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business, they support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right...

  • Regulatory QC Specialist

    4 weeks ago

    Cork, Cork, Ireland TN Ireland Full time

    Social network you want to login/join with:Reg affairs / Compliance QC specialistDescriptionMy client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business, they support the PDx vision of being the best-in-class supply chain delivering the right dose...

  • Regulatory Quality Specialist

    7 hours ago

    Cork, Cork, Ireland beBee Careers Full time

    Contrast Media Regulatory Specialist">Job OverviewThis role involves working as a QC Specialist in a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.The successful candidate will be responsible for managing pharmacopoeia reviews and resulting procedural changes, as well as supporting method validation...

  • QC Specialist

    1 day ago

    Cork, Cork, Ireland beBee Careers Full time

    QC Specialist - Biologics and Analytical DevelopmentWe are looking for a highly skilled QC Specialist to join our team in Biologics and Analytical Development. As a QC Specialist, you will be responsible for supporting the introduction of new biologic and solid oral dose products, ensuring their quality meets regulatory requirements. The successful candidate...

  • Contrast Media Regulatory Specialist

    13 hours ago

    Cork, Cork, Ireland beBee Careers Full time

    X-Ray and MRI Contrast Media Specialist">About the RoleWe are seeking an experienced QC Specialist to join our team at our manufacturing facility.The ideal candidate will have a strong background in chemistry or microbiology, and experience with regulatory compliance and quality control procedures.ResponsibilitiesReview and approve validation...

  • QC Compliance Specialist

    2 days ago

    Cork, Cork, Ireland beBee Careers Full time

    **Job Title:** QC Compliance SpecialistWe are seeking a highly skilled and experienced QC Compliance Specialist to join our team. In this role, you will play a key part in ensuring adherence to quality and safety standards within the laboratory.**Key Responsibilities:**

  • QC Specialist

    3 weeks ago

    Cork, Cork, Ireland Scientificjobs Full time

    QC Specialist – Method TransferMain Responsibilities:Planning and execution of method transfers, ensuring seamless transfer of analytical methods.Leading analytical investigations and problem-solving activities to resolve quality control issues.Preparing and writing analytical documents linked to the method transfer process.Validating and qualifying...

  • Temp QC Compliance Specialist

    2 weeks ago

    Cork, Cork, Ireland beBee Careers Full time

    Job DescriptionWe are seeking a highly skilled Temp QC Compliance Analyst to support the Quality Control organisation in meeting compliance targets through laboratory investigation and deviation management.The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs.A typical...

  • QC Specialist

    2 weeks ago

    Cork, Cork, Ireland Scientificjobs Full time

    QC specialist – Method Transfer Main Responsibilities Planning and execution of a methodtransfer Responsible foranalytical investigations and problem-solving activities Writing of analytical documents linked to the method transfer. Responsible of Validation / qualification of analytical equipment. Training of personnel for execution and...