Quality Operations Medolla

Quality Operations
Medolla
Emilia Romagna, Medolla

1-GENERAL DESCRIPTION**:

Be responsible for the management of Quality Assurance systems.

Be responsible to review GMP documentation to release APIs and finished products.

As QP, is responsible to manage and implement Company Batch Release procedures in accordance with the relevant EC Directives including 2001/82/EC and Annex 16 of the EU Guide to Good Manufacturing Practice.

- Provision of Quality oversight and support for Operations in the following key area/activities; manufacturing across all phases of development and commercial manufacture, packaging and materials management on site.

- Provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations.

- Review and approve executed manufacturing and packaging batch records

- Manufacturing and packaging operations Quality oversight

- Review and approval of Manufacturing and Lab investigations and CAPAs

- Laboratory and manufacturing Deviations and change control reviews for processes products and facilities

- Executed Manufacturing Batch record reviews

- Shop floor self-inspection, CAPA effectiveness follow ups.

- Health Authority, audits and inspections, commitment tracking, ensure on time commitment completion and monitoring of CAPA effectiveness.

- Feedback to site and platform Quality Councils and the Quality global compliance auditing function on the state of site compliance, inspection readiness, and progress against previous audit findings

- Establish Site internal audit plans & Site External suppliers/CMOs audit plans

- The VMP must be established and kept up to date by the local site owner of the operation (e. g.

head of manufacturing/technical services) and the responsible Quality Operations, Quality Systems and Quality Control Leads

- The responsible site Quality Ops unit ensures that the validation program is current, meets applicable regulatory requirements, and that the VMP is in compliance with the ZTS quality system

- Ensure that products are manufactured and packaged in compliance with GMPs and approved registrations.

- Co-ordinate Quality functions for assigned areas of responsibility and act as the key Quality Operations liaison between functional departments in Production, Quality and Commercial.

- Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology

- Develop people development and succession plans for the site Quality Operation function.

- Support the development of quality goals and targets as part of the organization's strategic plan.

**About Zoetis

At Zoetis we are passionate about our customers and the animals in their care.

We discover, develop and manufacture the world's most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry.

We know our people drive our success.

Our colleagues are proud of our company culture and the meaningful role we play in caring for animals.

The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day.

They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.

**Diversity, Equity & Inclusion

Our Colleagues Make the Difference, and we know their differences make Zoetis stronger.

We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day.

Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry.

Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives.

In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality, a 100 Best Company for Working Mothers, a Top Company for Executive Women, among many others.

For animals.

For health.

**For you.