Overview
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About Phibro Animal Health Corporation
Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition.
We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.
Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets.
In addition to, Phibro's revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.
At Phibro, people are our greatest asset.
We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.
If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.
The Qualified Person is an integral part of our Quality team based out of our Ireland - Sligo site.
Qualifications
Education
At least equivalent to a Level 8 qualification in a scientific discipline.
Successfully completed a recognised post-graduate course in Ireland that satisfies the educational requirements as defined in the Veterinary Medicinal Directive ****** (for example Masters in Pharmaceutical Science/QP).
Experience
Relevant pharmaceutical experience in compliance with Article 97 Veterinary Medicinal Directive ******, and fulfil the conditions required to act as a QP.
Experience as a named QP for a licensed facility is preferable.
Application of cGMP to manufacturing & testing.
Technical & compliance-based writing skills.
Experience in supporting inspections & internal audits.
Demonstrated stakeholder management & escalation experience.
Skills
Autonomy, self-motivation & efficiency with an appropriate sense of urgency in a fast-paced & dynamic environment.
Strong verbal & written skills with ability to explain complex, challenging issues clearly to all levels of the organization, especially management.
Strong interpersonal skills, including diplomacy & flexibility, with the ability to engage & influence effectively with key stakeholders.
Responsibilities
Ensure each commercial batch has been manufactured, tested & checked in compliance with Irish law following the requirements of the relevant marketing authorisation (MA) and confirming compliance with EU Guidelines for Good Manufacturing Practice & Annex 16: Certification by a Qualified Person & Batch Release.
Fulfil the ethical, professional, and legal duties of the QP as outlined by Article 97 Veterinary Medicinal Directive ******.
Acquire and maintain detailed knowledge for all GMP manufacturing steps for which the QP undertakes responsibility as part of the batch certification process.
Confirm the entire supply chain and robustness of associated pharmaceutical quality systems of the finished product lifecycle up to the stage of final batch certification, including the manufacturing and testing sites of all materials & packaging components for finished product & any other materials deemed critical through auditing & risk assessment of the manufacturing processes.
Confirm all sites of manufacture, analysis & certification are compliant with the terms of the MA for the intended market.
Responsible for confirming all audits of sites involved in the manufacture & the testing of medicinal products.
Confirm regulatory post-marketing commitments relating to manufacture or testing of the product have been addressed.
Ensure the impact of any change to product manufacturing or testing has been evaluated & any additional checks and tests are complete.
Confirm the required Quality Agreements are in place across the Supply Chain for the product & effective prior to batch certification.
Confirm the importation of active substances used in the manufacture of veterinary medicinal products complies with the requirements of Veterinary Medicinal Directive ******.
Support preparation for supervising competent authority HPRA & other regulatory audits.
Review relevant modifications of the Quality Management System (QMS), including new & updated GMP procedures, forms, & documentation in accordance with HPRA standards & requirements.
Cooperate in the exchange of information & assistance, as reasonably necessary to effectively respond to inquiries by regulatory authorities.
Review responses to regulatory audit findings.
Maintain a Continuous Professional Development plan, awareness of current Regulations & Guidelines, Legal Requirements & services of QP as stated under EU/HPRA Directive/Regulations or Guidelines.
Adhoc duties as required.
To learn more about Phibro Animal Health's competitive benefits package, please click here: Phibro Benefits .
Phibro is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.
Business Unit:Animal Health & Mineral Nutrition
Division:Animal Health & Nutrition
Department:Quality
Location:Ireland - Sligo
Work Schedule:Monday - Friday (40 Hours)
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