Regulatory Compliance Specialist- (1-2 years experience)

Orion Group Life Sciences have an exciting opportunity for a Regulatory Compliance Specialist for our Multinational Pharmaceutical client in Cork, Ireland on an initial 12-month contract.

Regulatory Compliance Specialist

Position Summary:
The JSI Regulatory Compliance Specialist is responsible for executing regulatory and
compliance related tasks and project activities supporting both the Quality Assurance and
Regulatory Affairs departments at JSI.

General Scope of Responsibilities
The JSI Regulatory Compliance Specialist for Quality Assurance/Regulatory Affairs is
responsible for completing regulatory requests for JSI in conjunction with the Regulatory
Compliance Team Lead.

Key Role Activities:

• Maintenance of the Clinical and Commercial Health Products Regulatory Authority (HPRA) Manufacturing Licenses by preparing and submitting application updates in a timely manner.
• Collaborate effectively with Notary Public on the management of notarisation and legalisation requests. Ensure availability of related PO's and appropriate logging and tracking of requests.
• Assist and co-ordinate with Regulatory Management on Country Specific Requests (CSRs) for initial registrations and renewals.
• Co-ordinate paper-based inspections for product renewals and new submissions as per Health Authority timelines.
  

Other Skills, Experience and Education

• Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance.
• Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated.
• Actively promote improvement programmes towards continuous compliance during qualification and validation. Actively promote and apply strategic thinking to compliance activities Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities.
• Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard.
• Interface with all site departments, Operations and Maintenance. Contact with Quality Assurance Manager for management of qualification and compliance activity.
• Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments.

Qualifications and Experience

Essential

• Bachelor's degree in a scientific/technical discipline required
• A minimum of 2 years' experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Desirable

• Experience in statistical sampling plan development.
• Experience in a biopharmaceutical or pharmaceutical plant startup.

For any further enquiries you can email Shane.mulcahy@orioneng.com

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.