Senior Quality Assurance Specialist, Drug Product
|Contact Name:||Larry O’Leary|
Our client, a blue-chip multinational pharma company, now seeks an experienced QA professional who can manage multiple stakeholders in the supply of pharmaceutical product to Global Markets.
The successful candidate will provide quality oversight in the manufacturing & supply for finished dosage forms or drug product from CMOs partners.
This position will suit an ambitious QA professional who wishes to transition to a dynamic, challenging and high rewarding virtual office environment.
This is permanent position based in Dublin and will require varying levels of travel, circa 20%.
Responsibilities of Senior Quality Assurance Specialist:
Management of CMO investigations, complaints, Quality Agreements & review and approval of Annual product reviews.
Review and approval of change control and supervision of CAPA evaluations and deviation management processes.
Efficiently support the selection of new contract manufacturing partners and suppliers for finished dosage forms or drug product.
Ability to work across cultures and geographies in an integrative manner.
Demonstrate knowledge and understanding of Regulatory requirements and filing process.
Drive Operational Excellence initiatives.
Confident management of internal and external stakeholder relationships.
Demonstrate excellent interpersonal skills within a team.
Requirements for Senior Quality Assurance Specialist:
BSc in either Chemistry or Microbiology or similar discipline.
5+ years' experience iyears in QA, Ops or Technical experience in pharmaceutical manufacturing for finished dosage forms or drug product.
Proven experience in the manufacture in some of the following areas: sterile, liquid, solids or API's is highly desirable.
Ideally candidates with have strong negotiation, superb communication and presentation skills.
Possess the ability to work well both on own initiative and across all levels, both internally and externally.
The ideal candidate will have a goal-oriented approach to project management coupled with the ability to manage simultaneous projects.
Operational Excellence qualification or Continuous improvement mindset is preferable.
For further details please contact Larry on +353 1 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie
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