Aptuit, Inc. QUALIFIED PERSON in Verona, Italy

  • Act as Qualified Person for Investigational Medicinal Products (IMP) and API, working independently in his/her functional responsibilities

  • Interact with Health Authorities to ensure compliance to cGMP and Regulations

  • Provide operational QP support to GMP areas ensuring on-time batch certification ad release

  • Facilitate the creation, implementation and maintenance of up-to-date GMP Quality Systems within Verona GMP Areas

  • Provide expert QA advice on GMP/CMC regulatory issues to Verona API, Drug Product e QC Departments

  • Act as Qualified Person for Clinical IMP batches and API according to the duties described in Articles 48 - 51 of Directive 2001/83/EC (implemented in Italy with D.Lgs 219/06)

  • Perform certification, final release or reject of batches of API and Drug Product (bulk, primary and secondary packed) for human use, according to Annex 13 and Annex 16 of Eudralex Vol. 4, covering also those cases where a batch has different stages of production or testing conducted at different locations or by different manufacturers

  • In his/her role, works with other company QPs to implement current directive(s), guideline(s) and decree(s) to guarantee full compliance to cGMP, assuring the effective interpretation and implementation of new and emerging GMP regulations

  • Work in partnership with Chemistry, Manufacturing & Control (CMC) areas and Project Management in Verona and provide advice from a quality perspective

  • Ensure that work generated within GMP Areas in Verona meets current regulatory expectations

  • Promote and maintain a high level of GMP awareness and compliance in CMC areas

  • Support CMC project teams by provision of expert cGMP advice

  • Participate to Quality Investigations and Complaints arising from deviation events in GMP areas affecting product quality and make recommendations for corrective and preventative actions

  • Contribute to the preparation and hosting of clients and regulatory inspections

  • Review and approve local Standard Operating Procedures

  • Drive the delivery and implementation of new Aptuit Quality Policies

  • Review and approve Quality Agreements with Clients

  • Accept any additional duties relating to cGMP expectations

Additional Responsibilities

  • Deputy Responsible person for Controlled Drugs management

  • Minimum 5-10 years in pharmaceutical industry, preferably in technical/QA areas, with at least 3 years in a QP role.

  • Experience in a Contract Development & Manufacturing Organisation (CDMO) environment as a preferred option

  • Fluency in English

  • Supportive team player

  • Good communication skills

  • Ability to lead and influence in complex situations

ID: 2018-3149

External Company Name: Aptuit, Inc.

External Company URL: http://www.aptuit.com/