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SENIOR COMPLIANCE SPECIALIST

 

Company:

MORGAN MCKINLEY

Job Reference Number

14576881

Client ID:

RI/476555AF

Posted On:

Mar 7 2012

Location:

DUBLIN, DUBLIN

Job Type:

Permanent

Salary:

EUR65K - EUR70K /A

Benefits:

  • BONUS
Senior Compliance Specialist

Responsibilities:
  • Independently schedules, conducts, and reports external foreign and domestic audit activities of a complex nature, such as API, Due Diligence, Sterile Production, and any other new technology or specialty facility audits.
  • Plan and strategize long term audit programs and department activities, such as inter facility training, internal site visits, and participate on various companywide teams and projects.
  • Provide guidance in managing and controlling the implementation of changes that may impact product quality and regulatory compliance.
  • Provide technical guidance and support to local plant Quality Operations functions by assessing, troubleshooting and recommending solutions to resolve compliance issues.
  • Contribution to various companywide harmonization efforts, e.g. supplier management, audit tracking modules, and training modules / programs is expected.
  • Stay current with Regulatory and Industry compliance trends and adopt auditing strategies as appropriate.


Person profile:
  • Minimum Bachelor's degree in a scientific discipline.
  • Minimum of 7+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. Medical device industry experience is a plus.
  • ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
  • Superior knowledge ofU.S.cGMPs and FDA guidance.
  • Superior knowledge of EU GMPs and ICH Guidances and International Standards (Risk Management, ICH 8, 9, 10)


Skills:
  • Strong interpersonal skills.
  • Effective organizational development skills.
  • Excellent written and verbal communication skills.
  • Effective influence management and conflict resolution abilities
  • Highly developed investigative and reporting skills.
  • Effective organization and time management skills.
  • Expected to work and grow in a team oriented environment and continue to build synergies between the Corporate compliance group and internal and external quality and manufacturing groups.


Abilities:
  • Ability to travel. (40%)
  • Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.