Quality Specialist - Document Control

Full Time
Tullamore, County Offaly
Posted
Job description

The Quality documentation Specialist will play an active role in support of the general site quality system, ensuring all site documentation for Quality Activities is managed through its lifecycle and assure its availability and readiness to support site operations.
The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA documentation processes across all disciplines. This role will manage site document archival requirements across the campus and with the external archival company.

This role will involve highly collaborative interaction with other stakeholders involved in the Greenfield project set up to ensure documentation activities meet all required timelines.

Position Responsibilities

1. Support of routine operations:
a. Ensure site Documentation is properly prepared and approved in accordance with the site Documentation Management System (Veeva Vault) and uploaded for training in the site Learning Management System.
b. Partner with the site Quality Systems Specialist to administer the site Learning Management System and ensure availability of documentation to support training.
c. Act as site Records Retention Coordinator for the site and manage control of all generated and executed records via relevant IT systems
d. Issuance and reconciliation of documentation and labels to all departments to meet batch and project schedules.
e. Communicate, collaborate, and cooperate all departments to support greenfield start up project.
f. Support and lead the handover and management of documentation from the greenfield project and manage the onboarding of documentation from external contractors to the Zoetis documentation management system/Archival process.
g. Lead the drafting and approval of a documentation plan for the handover of documents from the greenfield project to Zoetis.
h. Ensure all tasks applicable to the role are carried out in a safe manner.
i. Will be flexible to take on additional tasks and responsibilities at the discretion of the Quality Systems Lead.
j. Will act as a role model for the QA function and the wider organisation in adherence to the Zoetis corporate core values and local site shared commitments/behaviours.

2. Technical Support:
a. The role will require extensive liaison with all departments across the site and external vendors to support documentation requirements required to drive schedules and project timelines.
b. Author technical documents, including relevant SOPs, testing protocols and reports.
c. Serve as a technical lead for trouble shooting of Veeva vault and LMS software systems and other archival software as appropriate. Participate in applicable investigations, deviations and change controls associated with QA documentation activities.
d. Enhance collaborations by sharing knowledge and experiences across Zoetis global sites.
e. Interpret, oversee, and assure the implementation of corporate global policies, site and business specific guidelines and SOPs within the site technical services function.

3. Compliance & Continuous Improvements
a. Represent Quality team in regulatory inspections and internal audits as applicable.
b. Thorough understanding of current Good Manufacturing Practices.
c. Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence

Education and Experience

  • BSc in a relevant discipline (e.g., biochemistry, chemistry, process engineering) or equivalent experience
  • Experience in a Pharma /BioPharma Manufacturing environment
  • Demonstrated proficiency with Computer Skills with expertise in Microsoft Office (Word, Excel, PowerPoint, Visio, Access)
  • Strong written and oral communication skills and ability to collaborate effectively with others
  • Prior Experiences working with Documentation Management and Learning Management systems in a similar role an advantage.
  • Experience of interaction with cross-departmental teams.

Technical Skill Requirements

  • Excellent interpersonal, verbal, and written communication skills, meticulous eye for detail
  • Able to think critically and demonstrate troubleshooting and problem-solving skills
  • Self-starter and self-motivated; organised with good attention to detail
  • Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
  • Results oriented, with the ability to manage multiple priorities in a short period of time

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.

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