QA Ops Specialist

2 weeks ago

Dublin, Dublin City, Ireland Orion Group Full time

Orion Group Life Sciences are currently recruiting a QA Ops Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.

Responsibilities
  • Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
  • Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
  • Provides presence on the shop floor to support compliance and data integrity
  • Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
  • Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
  • QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
  • Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
  • Participates as the quality member on cross functional projects
  • Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
  • Provides support to internal audits and regulatory inspections
  • Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
  • Drive continuous improvement and utilise problem solving tools and MPS
  • Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues
Qualifications/Education

Required

  • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
  • This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
  • Evidence of leadership skills coupled with good oral and written communication skills
  • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

Preferred

  • Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
  • Demonstrated analytical aptitude, critical thinking skills and problem-solving skills
  • Demonstrated ability to upskill/coach others
  • Experience working on manufacturing shop floor
  • Familiarity with GMP documentation review and/or shop floor auditing
Seniority level
  • Associate
Employment type
  • Temporary
Job function
  • Quality Assurance
Industries
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr

  • QA Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland QCS Staffing Full time

    OverviewQA Specialist - Ireland, Dublin – 6 Months Initial ContractAre you a QA Specialist and wanting to join an international team working to improve the future of health care? Our client is a global health care company specialising in delivering lifesaving medicines globally. They have been at the forefront of delivering the health and well-being of...

  • QA Distribution Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full time

    OverviewQA Distribution Specialist - Life Science - Contract - DublinAre you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a QA Distribution Specialist to support the QA Distribution Specialist function.Located 15 minutes from Dublin Airport and just a short...

  • Pharmaceutical QA Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000

    QA Specialist for Pharmaceutical DistributionWe are seeking a highly skilled QA Specialist to support the QA Distribution function. The successful candidate will be responsible for ensuring quality oversight of temperature controlled product activities, assessing shipments, and providing guidance on quality issues related to temperature controlled...

  • Qa Specialist

    7 days ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Dublin, Ireland - 12 Months ContractOne of the top 10 best companies to work in Ireland is looking for QA Specialistfor their large-scale new facility in Dublin.Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project.This fantastic client offers...

  • Qa Senior Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with SK pharmteco are hiring a permanent QA Senior Specialistto join QA Systems team for their site in Swords, Co.Dublin.ABOUT US?SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland.We are part of SK Inc., a Korean company with revenues of $99...

  • QA Operations Specialist

    4 days ago

    Dublin, Dublin City, Ireland beBeeOperational Full time €60,000 - €80,000

    Operations Shift SpecialistWe are seeking an experienced Operations Shift Specialist to join our team. This role is ideal for a seasoned professional with expertise in QA operations and regulatory agency engagement.Key Responsibilities:Support the efficient operation of quality assurance processesCollaborate with cross-functional teams to ensure seamless...

  • QA Specialist

    2 days ago

    Dublin, Dublin City, Ireland Claran Consultants Ltd Full time

    An exciting opportunity has arisen for a Quality Assurance COE (Centre of Excellence) Specialist to join our team in Biotech Swords, Co. Dublin. The role ensures that the QA team objectives are effectively achieved, consistent with the companys requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency...

  • Qa Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Specialist - Ireland, Dublin - 6 Months Initial ContractAre you aQA Specialist and wanting to join an international team working to improve the future of health care?Do you want to enhance the lives of millions of people?QCS Staffing's client is a global health care company specialising in delivering lifesaving medicines globally.Our client has been at...

  • Electrical QA/QC Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland Specialist Technical Services (STS Group) Full time

    OverviewElectrical QA/QC Engineer - Cork/Dublin role at Specialist Technical Services (STS Group). STS Group is seeking an experienced QA/QC Technician or Engineer to join Life Sciences (pharma) projects in Cork or Dublin.Responsibilities Prepare handover testpacks and operation & maintenance manuals. Review and issue final handover documentation to the...

  • QA Senior Specialist Compliance

    2 days ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    QA Senior Specialist Compliance - Ireland, Dublin - 6 Months ContractOne of the top 10 best companies to work in Ireland is looking for a QA Senior Specialist Compliance for their large-scale new facility in Dublin. Is this you?An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion...