Benefits:
Bonus, Parking, Pension, Life Assurance, Canteen, Educational assistance
Description:
This is a full-time permanent role and an attractive remuneration package will be offered to the successful candidate.
Applications are invited from candidates who meet the following criteria.
O Minimum Bachelor's degree in a scientific discipline.
O Minimum of 7+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. Medical device industry experience is a plus.
O ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
O Superior knowledge ofU.S.cGMPs and FDA guidance.
O Superior knowledge of EU GMPs and ICH Guidances and International Standards (Risk Management, ICH 8, 9, 10)
o Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.
O Available to travel 40-50%
Responsibilities of the role will include the following:
o Independently schedules, conducts, and reports external foreign and domestic audit activities.
O Plan and strategize long term audit programs and department activities.
O Provide guidance in managing and controlling the implementation of changes that may impact product quality and regulatory compliance.
O Provide technical guidance and support to local plant Quality Operations functions.
O Contribution to various companywide harmonization efforts.
O Stay current with Regulatory and Industry compliance trends and adopt auditing strategies as appropriate.
For a full Job Spec and to find out more about this role please call Deirdre at +353 1 2784671 or e-mail your CV in the strictest confidence to dbolger@thornshaw.com
Log on to www.thornshaw.com for more jobs.
Key words: QA, Quality Assurance, GMP, Pharmaceutical, Compliance, Regulatory, Auditor, Medical Device, Ireland, Ireland Jobs, Risk management, ICH, FDA