Qualified Person (QP)

Sigmar Recruitment

Dublin South

QUALIFIED PERSON QP. RESPONSIBILITIES: For the Manufacturing license, act as one of the Company’s Qualified Persons in accordance with EU Directive 2001/83/EC. To act as the QP for the production plant. Role of QP to include Direct contact with relevant production Coordinator on GMP issues. Cooperation with Production to ensure continuous improvement. Provide details on corrective actions required for batch deviations. Assist in the implementation of Quality Systems within production to ensure compliance with GMP. Provide regular feedback to other QP’s on main issues. To act as QA representative on major projects as required. Communication / liaison with other departments. Participate in the vendor audit program. Participate in the self-inspection programme. To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required. Maintenance of the Quality Systems. REQUIREMENTS: Possesses suitable educational background that meets the requirements of Article 49 of Directive 2001/83/EC. Have a minimum of five years experience in the Pharmaceutical Industry in a QA role. Direct QP experience in solid oral dosage manufacture and/or packaging is preferable - but must be QP eligible. Please review the requirements for this role and apply to Clara Henry on chenry@sigmar.ie or phone 01 4744676 for more detail. This job originally appeared on RecruitIreland.com.

2163 days ago