Quality Assurance Shop Floor Manager

5 mesi fa

Sesto Fiorentino, Italia Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Quality Assurance Shop Floor Manager assists the Associate Director QA in managing the team’s daily workload, performance evaluation, issue resolution, training, and personal development of employees. The QA Manager support QA shop floor personnel serving a specific function to achieve site goals while maintaining a strong quality mindset. The Manager is also responsible for single contributor activities that may include: process owner, SOP / training owner, and technical expertise, as well as process improvements.

**Responsibilities**:
**1. Quality**
- Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations, specifically in regard to the following areas as they relate to manufacturing processes and Quality systems.
- Change control: evaluate and assess impact and action plans of proposed changes to validated processes, direct impact equipment, and regulatory commitments.
- Deviations: Assure proper root cause identification and establishment of effective corrective action plans to prevent re-occurrence. Ensure investigations are completed in an appropriate and timely manner. Assure adequate identification of trends and generation of applicable action plans.
- Periodic Reviews: Assure periodic reviews are conducted in an appropriate and timely manner. Assure adequate identification of trends and generation of applicable action plans.
- SOPs: Assure adequate procedures are available to cover all activities related to GMPs. Assure personnel affected have been properly trained in the SOP content.

**2. People**

**Education, Training, and Administrative**
- Assure all direct reports have assigned individual training plans according to their roles and responsibilities.
- Assure compliance with individual training plans.
- Identify and refine training needs to fill capability gaps. Ensure people are cross-trained to adequately meet the business needs.
- Oversee the performance management process and development plans for all direct reports, ensuring the plans are aligned with site, Quality, and individual objectives.
- Provide consultation or conduct training for GMP procedures as needed.
- Continually evaluate, maintain, and improve processes within Quality
- Provide a good interface between upper management and associate level employees.
- Maintain open team communication through one-on-one and team staff meetings.

**Organization**
- Assure Quality Unit decisions regarding quality assurance issues are maintained independently from the Business Unit.
- Support inspection readiness activities such as site self-assessments to ensure the site is constantly in a state of inspection readiness.
- Assess gaps between local and corporate standards and facilitate efforts to remediate gaps.

**3. Regulatory and Company Requirements**
- Observe, promote, and comply with regulatory requirements and corporate standards related to quality systems, safety, security, and GMP.
- Assure compliance. with regulatory commitments.
- Provide aid and guidance in deviation investigations, change control proposals, procedures, validation, and batch dispositions.
- Assist and investigate deviation
- Maintain and improve Quality Systems.
- Escalate notification to management of any violation or departure and assure the issue is being addressed.

**Requirements**:

- Master’s degree in science related field
- English fluencY
- Knowledge of computerized systems, regulations, and cGMP’s.
- Ability to prioritize and complete multiple tasks at any given time.
- Previous experience in Quality Assuranc
- Ability to organize and prioritize multiple tasks.
- Ability to effectively communicate with customers to reinforce requirements.
- Experience and knowledge of cGMP requirements.
- Ability to work independently
- Decision-making skills and ability to exert good judgment
- Flexibility
- Problem solving skills
- To work under time pressure

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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