QA Operations Compliance Specialist (Biologics) at Dillon Engineering Services
Sligo, County Sligo, Ireland -
Full Time


Start Date

Immediate

Expiry Date

19 Sep, 25

Salary

30.0

Posted On

19 Jun, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Aseptic Processing, Biologics, Finish

Industry

Pharmaceuticals

Description

Job Title: Quality Operations Compliance Specialist
Location: Sligo, Ireland
Job Type: Contract
Duration: 12 months
Rate: €30 - €40 per hour
Ref Code: DES-1023
Dillon Engineering Services is seeking an experienced Quality Operations Compliance Specialist for our client, a global biopharmaceutical company. You will join the Quality Assurance team onsite in Sligo, reporting to the Quality Operations Manager.

REQUIREMENTS

  • Third-level degree in science, quality, or engineering.
  • Minimum 3 years’ experience in quality/operations in a GMP-regulated environment (biologics preferred).
  • Experience in aseptic processing, including isolator technology and single-use assemblies.
  • Strong regulatory knowledge and confident decision-making skills.
  • Batch record review and investigation experience.
    Candidates must have valid visa/citizenship to work in Ireland/Europe.
    For more information, contact Corné at 094 931 6002 or corne@dillones.ie.
Responsibilities
  • Ensure all products meet regulatory and company standards for marketed and investigational drug products.
  • Provide quality and compliance oversight to Operations to ensure GMP compliance.
  • Support aseptic processing oversight, including intervention observation.
  • Lead/assist in investigations related to product or process non-compliance.
  • Review batch records, manufacturing logs, and operations documentation (SOPs, JSTMs, risk assessments).
  • Conduct line clearance activities and incoming raw material checks.
  • Provide stability program support, including sample pulls and protocol generation.
  • Maintain finished product status, including labelling.
  • Administer quality logs (e.g., QA Hold, Sample Requests).
  • Conduct daily walkarounds of manufacturing areas.
  • Drive continuous improvements in compliance and site processes.
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