We are currently looking for a GMP QA, within the Verona GMP Quality Assurance organization.
The role will report to GMP QA Manufacturing Projects Supervisor, will work closely with QA colleagues in supporting the operations in the daily activities. The resource will liaise mainly with local internal stakeholders in the management of Quality System Documents and tasks, ensuring compliance, alignment to regulation, internal procedures and promoting continuous improvement.

In detail, the resource will be involved in different activities to cover on priority the following QA project related responsibilities.

• Provide QA support to API and Clinical Drug Product Manufacturing in terms of GMP compliance as QA representative in the team project;
• Work in partnership with Pharmaceutical Development Department and Project Management in Verona and provide advice to the project from a quality perspective giving support in the internal meetings and meetings with customer;
• Review and approve documentation related to GMP project (e.g. Master Batch Records, Pre-Executed batch record, Batch records (both for API and DP));
• Cooperate to process mapping and review in order to ensure compliance and improve process effectiveness
• Write, review and approve Standard Operating Procedures and any other GMP relevant document or statement;
• Review and approve deviations in accordance with Aptuit standards and procedures. Follow up on the implementation of corrective and preventative actions;
• Support the evaluation of CAPA efficacy;
• Ensure QA support and advice in the cleaning verification management;
• Collaborate in issuing internal Risk assessment documents;
• Manage the set-up of Quality Agreements with Clients;

The requested level of collaboration/engagement in each activity will depend on the personal training on the job, general gained level of GMP knowledge and his /her specific role assigned in the organization. Training programme will detail the prioritized acitivities.

Other Duties

• Support the team in the improvement of the quality culture of the site
• Promote and maintain a high level of GMP awareness and compliance in GMP areas;
• Support allocated project teams by provision of cGMP advice;
• Propose and promote QA learning points taken from experience.

Preferable

• Previous experience in GxP area (e.g.: GxP training available)
• Office 365 package, Veeva, CometA, iSILA, iDREAMS, iSTRM

Qualifications, competences and abilities for the role

• Good listening, communication and team working skills, with ability to interact across stakeholders.
• Good creative, technical, innovative and problem-solving skills.
• Good written and spoken English.
• Demonstrated ability to prioritize and manage multiple activities.
• Demonstrated flexibility in adjusting to a rapidly changing workload and attitude to provide support to colleagues during times of high stress.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

In detail, the resource will be involved in different activities to cover on priority the following QA project related responsibilities.

• Provide QA support to API and Clinical Drug Product Manufacturing in terms of GMP compliance as QA representative in the team project;
• Work in partnership with Pharmaceutical Development Department and Project Management in Verona and provide advice to the project from a quality perspective giving support in the internal meetings and meetings with customer;
• Review and approve documentation related to GMP project (e.g. Master Batch Records, Pre-Executed batch record, Batch records (both for API and DP));
• Cooperate to process mapping and review in order to ensure compliance and improve process effectiveness
• Write, review and approve Standard Operating Procedures and any other GMP relevant document or statement;
• Review and approve deviations in accordance with Aptuit standards and procedures. Follow up on the implementation of corrective and preventative actions;
• Support the evaluation of CAPA efficacy;
• Ensure QA support and advice in the cleaning verification management;
• Collaborate in issuing internal Risk assessment documents;
• Manage the set-up of Quality Agreements with Clients

Other Duties

• Support the team in the improvement of the quality culture of the site
• Promote and maintain a high level of GMP awareness and compliance in GMP areas;
• Support allocated project teams by provision of cGMP advice;
• Propose and promote QA learning points taken from experience

Qualifications, competences and abilities for the role

• Good listening, communication and team working skills, with ability to interact across stakeholders.
• Good creative, technical, innovative and problem-solving skills.
• Good written and spoken English.
• Demonstrated ability to prioritize and manage multiple activities.
• Demonstrated flexibility in adjusting to a rapidly changing workload and attitude to provide support to colleagues during times of high stress