Job Description
The Packaging Engineer Contractor will:
The Packing Engineer role will manage all the documentation requirements of Packaging Engineers to facilitate Legal Entity Organisation, MAH changes resulting from the Integration of multiple acquired organisations and products.
Knowledge of cGMP documentation requirements a must
Knowledge of developing and qualifying a sturdy packaging component a must
Management (development, review and approval of) new and modifications to technical profile drawings and purchasing/release specifications a must.
Knowledge, experience and SME in electronic documentation, change control, deviation and CAPA a must (Trackwise a must; FOCUS, SPOT and EQMS/Veeva a plus)
Knowledge of Master Data documentation processes to modify master data (for serialised product) impacted by LEO changes.
Ability to multitask and achieve tactical deliverables with little to no supervision, post training.
Support team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply.
the development (input), launch, life cycle management and continuous improvement of primary and/or,
Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations
Manage implementation of platform (harmonisation / standardisation) components
Manage bill of materials, etc.
Technical/Functional (Line) Expertise
cGMP SME in packaging
Technical specification, profile drawing development (Auto Cad, etc.)
Specification development, review, approval and implementation
Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must)
Essential:
Bachelor’s Degree in an engineering related field; Packaging Engineers preferred.
5 years pharmaceutical experience (or equivalent)
Strong knowledge of cGMP documentation requirements
Strong technical, interpersonal, communication and leadership skills.
Knowledge of electronic documentation systems (MUST: Trackwise)
For further information on this Packaging Engineer Contractor position please contact Laurentina Kennedy at The RFT Group on 01 2302400 /Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: ?www.rftgroup.ie
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