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REGULATORY COMPLIANCE SPECIALIST

 

Company:

BRUNEL RECRUITMENT
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Job Reference Number

14291716

Client ID:

RI/BT891257REG
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Posted On:

Mar 9 2010

Location:

CORK, CORK
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Job Type:

Contract

Salary:

EUR33K - EUR35K /A + PAID HOLIDAYS,
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Benefits:
  • SPORTS & SOCIAL CLUB
  • SUBSIDISED CANTEEN
  • CAR PARKING
The successful candidate will report into the Regulatory Compliance Manager, the Regulatory Compliance Officer works as part of the QA Regulatory Compliance team, which is responsible for coordinating day-to-day regulatory, registration and compliance activities and advising the business in the area of regulatory compliance.

Responsibilities

As the Regulatory Compliance Officer, you will provide:
* Support to ensure maintenance of regulatory compliance in all departments
* Management of site change control process
* Maintenance of Site Master File & manufacturing license
* Participation in new Internal Audit process
* Participation in the Site Inspection Readiness Program and Corporate compliance audits/External Inspections (IMB, FDA)
* Review & Approval of validation & analytical documentation, as required to support regulatory compliance within the plant
* Streamlining and implementing Process Improvement initiatives for the current Product Quality Review (PQR) process
* Updating Technical Agreements process & revision of current Technical agreements
* Implementation of Process Improvement initiatives for the RA processes
* QA representative on site projects & process improvement teams
* Frontline response to regulatory compliance queries from all departments
* Provide support to routine activities and training relevant to area of expertise
* Support the development and maintenance of Quality System metrics
* Maintain & keep quality procedures up to date and reflective of regulatory requirements.
* Supporting the preparation and execution of Quality Management Reviews at the site and P&L &GEHC levels.
* Assess regulatory impact on product and manufacturing processes. This may include acting as quality expert and approval/authorisation of regulatory specifications and submissions.

Qualifications/Requirements

1.Diploma/Degree in Science-based discipline or equivalent
2.Minimum of 2-year experience in the quality assurance/control/regulatory function of the medical device or pharmaceutical industry
3.Minimum of 2-year experience applying regulations (including FDA, cGxP)
4.Proficient with relevant MS Office applications.
5.Ability to identify root cause of problem and creatively problem solve to gain resolution.
6.Ability to communicate effectively in English (both written and oral).
7.Ability to work independently in fast-paced environment with little supervision.
8.Ability to adapt to constant change and influence positive change effectively.
9.Team-oriented and responsive to customer needs.
10.Quality-Focused, Attentive to Detail and Results-Oriented.