Job Description

Principal
Responsibilities:

Responsible for QA oversight of
cold chain activities in all markets in accordance with local and international
requirements and planning schedules; ensure products shipments are
managed in accordance with GDP’s requirements.
Ensuring QA distribution batch
release of shipments at the 3PL Distribution centers.
Assess cold chain shipments and
provides corresponding quality decision on product.
Review documentation including change
controls, deviations, validation documentation, SOPs and specifications.
Ensure Quality Agreement with distribution contractors and carriers are established and maintained.
Assess and process product
returns in conjunction with Logistics team.
Provide Quality and
compliance support to projects impacting Distribution site
activities.


Requirements

Qualifications:

·         3+ years QA experience in a
HPRA/FDA/EU & GDP regulated environment

·         Knowledge of Cold Chain
activities

·         Knowledge of GDP and global
regulatory requirements

·         Sound awareness and understanding
of pharmaceutical and biotech business, especially with regards to quality and
regulatory requirements

·         Strong Interpersonal skills and
ability to interact constructively with all functions in a matrix organization
environment

·         Good verbal and written
communication skills with well-structured communication and ability to present
to various audience levels

 

Education:

  • Degree in natural or applied
    sciences (Pharmacy, chemistry, biotechnology, engineering)

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