Senior Quality Assurance Associate

3 days ago

Dublin, Dublin City, Ireland PE Global Full time
Senior Recruitment Consultant @ PE Global

Description:

PE Global is currently recruiting for a Senior QA Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

This is a shift position. The shift patterns are as follows: 07:00 to 19:00, and 19:00 to 07:00. (4 on, 4 off).

Overview

The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team.

As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.

This is a 24/7 shift role required to support manufacturing operations.

Responsibilities
  • Ensure adherence to safety standards and SOPs in all activities.
  • Review and approve production batch records and associated documentation for Qualified Person disposition activities.
  • Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
  • Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
  • Offer Quality Assurance support for on-the-floor investigations and deviations.
  • Review and approve deviations for closure, ensuring compliance with appropriate documentation.
  • Participate in customer complaint investigations.
  • Conduct routine Quality Assurance walks on the production floor.
  • Review and issue logbooks, ensuring compliance with procedures.
  • Provide training and guidance to staff for effective performance.
  • Review and approve cGMP records, ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.
Qualifications
  • Minimum Qualification: Science Degree / Engineering degree
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Demonstrated ability in problem solving particularly in supporting non-conformance/deviation investigations.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on or alternatively send an up to date CV to

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland

Job Details
  • Seniority level: Associate
  • Employment type: Contract
  • Job function: Quality Assurance
  • Industries: Staffing and Recruiting
#J-18808-Ljbffr

  • Senior Quality Assurance Associate

    4 days ago

    Dublin, Dublin City, Ireland beBeeQualityAssurance Full time €60,000 - €75,000

    Job Title: Senior Quality Assurance AssociateWe are currently seeking a skilled Senior Quality Assurance Associate to join our team. As a key member of the quality control department, you will be responsible for planning and performing multiple complex routine/non-routine methods and procedures.Key Responsibilities:Plan and perform analyses with great...

  • Quality Assurance Associate

    3 days ago

    Dublin, Dublin City, Ireland Next Generation Full time

    OverviewMy client is seeking a Quality Assurance Associate (QMS) to support the development and maintenance of the company's Pharmaceutical Quality System. This role will focus on the day-to-day processing of change controls and the generation and communication of Change Control KPIs. It will also involve managing key quality system elements including...

  • Quality Assurance Associate

    3 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000

    Job Title: Quality Assurance SpecialistThe Quality Assurance Specialist will be responsible for ensuring the quality and integrity of our manufacturing operations. This is a key role within our site QA team, reporting to a Senior QA Manager.Responsibilities:Perform all activities in compliance with Amgen safety standards and standard operating...

  • QA Senior Associate

    4 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €72,920 - €99,105

    Life Science Consultants are seeking a skilled QA Senior Associate to fill key roles. This is an exciting opportunity for experienced professionals to contribute their expertise in quality assurance and regulatory compliance.Key ResponsibilitiesReview and approve production batch records and associated documentation for Qualified Person disposition...

  • Senior Quality Assurance Specialist

    3 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €30,000 - €40,000

    Job Title:Biotech Plant Quality Assurance AnalystAbout the Role:We are seeking an experienced Quality Assurance Specialist to join our team at a leading international Biotechnology company.The Senior Associate for Plant Quality Assurance (PQA) will report to the QA Manager and play a pivotal role in the site's Quality Assurance team.As the Quality point of...

  • EMEA Quality Assurance Associate

    5 days ago

    Dublin, Dublin City, Ireland JPMorgan Chase & Co. Full time

    EMEA Quality Assurance Associate - Monitoring and TestingJob Description Join thepliance, Conduct & Operational Risk (CCOR) Quality Assurance Monitoring and Testing (M&T) team as a Quality Associate. As part of Risk Management andpliance, you are at the center of keeping JPMorgan Chase strong and resilient. You help the firm grow its business in a...

  • Quality Assurance Associate

    3 days ago

    Dublin, Dublin City, Ireland beBeeCustomerSupport Full time €45,000 - €60,000

    As a Quality Assurance Associate, you will be responsible for delivering exceptional customer service and technical support to resolve complex issues in a timely manner.Main Responsibilities:Provide technical assistance to customers via various channelsFoster collaboration with cross-functional teams to ensure prompt issue resolutionMaintain accurate...

  • Clinical Quality Assurance Associate

    4 weeks ago

    Dublin, Dublin City, Ireland WEP Clinical Full time

    Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a...

  • Quality Assurance Specialist

    3 days ago

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

    Job Overview">The Plant Quality Assurance (QA) Senior Associate is a key member of the site QA team, reporting to a Senior QA Manager. This role involves serving as the quality point of contact for manufacturing operations, with a focus on ensuring compliance with Amgen safety standards and standard operating procedures.">Responsibilities:">Perform all...

  • Quality Assurance Specialist

    2 days ago

    Dublin, Dublin City, Ireland beBeequality Full time €45,000 - €70,000

    Job Title: Quality Assurance SpecialistThe company is seeking a dedicated Quality Assurance Associate to join their team. As a Quality Assurance Associate, you will play a key role in ensuring the quality of products and services.",