Position Summary
The Manufacturing Investigator is a key team member within the Manufacturing Department. The
Manufacturing Investigator uses expert knowledge of compliance and GXP manufacturing processes to
lead staff and demonstrate best practices in the management of investigations and improvement initiatives within manufacturing operations. This role will include responsibility for the successful completion of deviations, as well as the identification and implementation of corrective/preventative actions, within
their organization. This individual is responsible for maintaining deviation timelines and escalating when they cannot be met, as well as mentoring others on cGMP expectations. The individual must demonstrate an in-depth understanding of their areas' processes and procedures, as well as cGDPs and cGMPs, and applies them to investigation and documentation of deviation root cause and compliance impact. The individual will be responsible for analysing performance metrics and identifying trends and implementing actions to improve performance and compliance in their area.
Position Responsibilities
- Gathering data from various sources across the site, performance of Root Cause
- Analysis (RCA) using tools such as fishbone diagrams, "5 Whys", Process mapping to
- determine the most likely cause, perform trending analysis, identification of Corrective
- and Preventative Actions to reduce deviation recurrence, performance of Risk
- Assessments such as FMEA's.
- Technical writing, translating very complex and challenging scientific events into a
- brief and cohesive report as a finished product.
- Work on the manufacturing floor for data gathering and observing of processes for
- investigations.
- Apply Site and Global compliance SOPs to investigations.
- Provide technical input and support writing of technical reports required for regulatory
- purposes.
- Participate in Quality and Safety regulatory audits.
Organisational Relationships
- This role will include working with teams, both in Zoetis Tullamore and externally with Contract
- Manufacturing Organisations.
- The role will involve interation with USP, and DSP within the manufacturing department and with
- external stake holders such as QC, WHSE and ENG.
- The role will require strong interaction with QA.
Education and Experience
* BSc, MSc, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or
equivalent experience.
* 2-5 years' relevant experience in bioprocess development and/or manufacturing
* Knowledge of Cell culture and protein purification
* Working in a controlled regulated environment e.g. GMP/GLP.
* Experience working with external contractors.
* Excellent project management capability.
* Excellent verbal and written communication skills. Ability to maintain very clear records of work
completed.
* Ability to work effectively as part of a team across all departments in Zoetis Tullamore.
Technical Skills Requirements
* Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint
desirable.
* Ability to work in a cross functional team environment.
* Applies knowledge and subject matter expertise to ensure end-to-end of investigations.
* Anticipates and prevents potential issues with regulators.
* Own and/or Drive Improvement projects/initiatives.
* Management of multiple projects and timelines concurrently. Ability to adhere to standard
timeline and escalate actions appropriately for resolution in a timely manner.
Physical Position Requirements
This will primarily be desk based. There will be a requirement to support out of hours activities on
occasion.
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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