QP

Job Description

Sligo and Dublin are both on a search of Qualified Person (QP ) to join their pharmaceutical team on a 12 month contract

Job Purpose:

Act as a Qualified Person in accordance with EU Directive 2001/83/EC. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.

Key Responsibilities:

• To act as the QP for one of the production plants.
• 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 for relevant production plant
• To act as QA representative on major projects as required.
• Communication / liaison with other departments.
• Participate fully in any cross-functional training initiatives.
• 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

Educational and Additional Requirements:

• Have a minimum of five years' experience in the Pharmaceutical Industry in a QA role.
• QP experience in API or SOD manufacture and/or packaging is preferable.
• Good organizational, investigational & technical writing skills are required

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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