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Compliance Officer

Date: Jan 4, 2019

Location: Waterford, IE, X19

Company: Teva Pharmaceuticals

Company Info

We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

We estimate that Teva provides medicines to 200 million patients around the world every day.

We develop, produce and market affordable generic medicines, as well as innovative and specialty pharmaceuticals and over-the-counter consumer healthcare products, along with supplying active pharmaceutical ingredients to nearly 1,000 customers in over 100 countries.

We work tirelessly to transform science, research and patient insights into effective treatments for disorders of the central nervous system, pain and respiratory conditions

Job Description

We would like to invite applications for the role of Compliance Officer at our Waterford site. As Compliance Officer you will be responsible to ensure Teva Pharmaceuticals Ireland’s Business Units operate in accordance with Regulatory, Company and Corporate requirements by providing compliance support and advice as required.

 

 

 

Key responsibilities

 

•     To complete internal and vendor audits, document review and approval and project support as requested.

•     To support Site Compliance Systems with a specific focus on the following areas:

  •           Internal and Vendor Audit Programmes
  •           CAPA System
  •           Regulatory Environment Awareness
  •           Global Gap assessments

•     To support preparation for customer/regulatory inspections.

•     Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements.

•     Generation and approval of Quality Technical Agreements.

•     To participate and project manage Compliance and Company projects as required to ensure continuous improvements for quality systems.

•     To identify areas for improvement and take corrective action as required.

•     To deliver Customer Service (both internal and external) through agreed timelines in accordance with quality standards and cost control.

Qualifications

 

Minimum:

 

•             Qualification in a Scientific or other relevant discipline (or in the process of gaining a 3rd level scientific qualification).

•             Proven experience in a Quality/Compliance role or a GMP environment

•             Regulations and sources of regulatory information – FDA and HPRA.

•             cGMP requirements

 

Skills:

 

•             Technical report writing skills

•             Excellent Computer skills.

•             Communication skills - verbal / written.

•             Auditing skills/experience

 

Function

Quality

Sub Function

Quality Compliance

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.