QA Ops Specialist
FTC 12 Months – Dublin North
Excellent salary and benefits attached.
Recruitment are once again assisting our reputable client in the North
Dublin area to source a Quality Ops Specialist, Drug
Product, EMEA and Asia Pacific, to provide quality and compliance
oversight support to the Quality Operations management team within External
Key Duties and Responsibilities:
the coordination of quality events, change control and market complaints
programs in respect of Third Party Manufacturer and Alliance Partnership
support the Fact Finding and
Product Review Committee processes for
major investigations involving Third Party products.
quality/compliance support to the wider Supplier Relationship Management,
Global Procurement, Supply Chain and MT teams in support of new projects,
technical transfers programs, supplier selection programs, investigations,
validation programs etc.
the requisite quality support to Global functional groups such as Global
Regulatory/CMC and the local country based regulatory managers in support of
regulatory filings, product renewals, regulatory agency questions etc.
quality metrics programs in relation to Third Party performance.
support to Quality Operations Management Team in Technical Transfer projects
and Manufacturing Launch Teams (MLTs) relating to Third Parties.
in the preparation of Quality Agreements with the Third Party Manufacturers and
the Annual Product Reviews submitted by the Third Party Manufacturers.
the Global external auditing program by participation in audits of Third
Parties as requested.
support to specified quality and technical projects as they arise.
Qualifications, Knowledge and Skills Required:
to develop cross-functional and external working relationships
communication and presentation skills across all levels .
analytical and problem solving skills.
BSc in a scientific discipline such as Chemistry or Microbiology combined with
a minimum 5 years experience in the pharmaceutical industry, preferably in
Quality, Manufacturing Technology, Regulatory or a position within a Health
For a confidential
discussion, reach out to email@example.com