Job Description
Quality Assurance Manager
Our client is a young exciting and ambitious pharmaceutical company with a newly created vacancy for a right capable Senior Quality Assurance ManagerQuality Management System
Our client is a young exciting and ambitious pharmaceutical company with a newly created vacancy for a right capable Senior Quality Assurance ManagerQuality Management System
Continuing development, implementation, and maintenance of the Quality Management System
Management of deviations, CAPA's and change control notifications associated with commercial products.
Operation and maintenance of quality documentation system.
Preparation and delivery of training on QMS, SOP, and processes.
Develop and report quality metrics.
Coordinate leading periodic review of the QMS and management review.
Participating in the preparation of annual reports, annual product reviews, and core documents.
Vendor evaluation and audit and internal quality review.
Person Spec :
8-10 years' experience gained in finished product pharmaceutical manufacturing (preferably aseptic/sterile) is required (Knowledge of QA for all pharmaceutical dosage forms and drug substance
manufacture is desirable)
Bachelor's degree in chemistry, biology or a related discipline (Masters/Ph.D. level preferably/ QP qualified a bonus)
An excellent understanding of quality guidelines (both GMP/GDP) and CMC/WDA regulatory requirements and prior experience working on technical content for regulatory submissions desirable.
(Experience dealing with HPRA desirable)
A strong understanding of and experience in quality management is essential.
Previous experience of Third party/Vendor/CMO management/Contract manufacturing and virtual manufacturing space desirable.
Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem-solving and issue resolution is also required.
CV to Laurentina Kennedy at The RFT Group at laurentina@rftgroup.ie / 01 2302400/ www.rftgroup.ie