Quality Operations and Product Disposition Senior Specialist

POSITION SUMMARY

The Quality Operations and Product Disposition Senior Specialist will have an active role in batch review and certification for batches manufactured on site as well as partaking in batch review and certification of outsourced manufacturing & testing activities. Participate in the establishment, continuous improvement and maintenance of the quality management system.

In addition, assume an active role in internal and external audits, outsourced activities, equipment qualification reviews, analytical data review and interface with cross functional departments on quality matters.

The role will also ensure that all Manufacturing and Product release activities are in alignment with Zoetis Registrations and Regulatory Compliance.

POSITION RESPONSIBILITIES

Review & approval of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of current Good Manufacturing Practices (cGMP) and batch review and batch disposition process.

Partake in QA documentation management, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.

Support change management, deviations and corrective and preventative action (CAPA) systems as required.

Support ongoing review of events, deviations and non-conformances associated with batch release activities.

Support site risk management procedures.

Support ongoing running and maintenance of Electronic Quality Management System.

Support the implementation and continuous improvement of an effective quality management system including quality oversight across the site.

Write or assist in writing, reviewing and approval of SOPs and other GMP documents.

Provide QA support to Quality Control including review of Quality Control (QC) raw data.

Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursions.

Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved.

Support the ongoing site training system and deliver training modules where required

Participate in or lead internal and external audit including 3rd party audits and supplier reviews.

Participate in ongoing site data integrity projects.

Manage specific projects that may arise, in a timely and efficient manner.

Assist in supporting the qualification and periodic review of equipment.

Participate in set up of new electronic systems where required.

Overview product and cell bank stability programmes, submission of samples, filing of results and providing updates.

ORGANIZATIONAL RELATIONSHIPS

Working closely with multiple groups for fast-moving projects to ensure proper and timely communication

The role will involve interaction with internal departments QC, Production and Engineering primarily.

EDUCATION AND EXPERIENCE

Third level Degree in a life science discipline.

At least 5 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.

Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including Quality by Design (QbD) and Risk Management.

TECHNICAL SKILLS REQUIREMENTS

Experience of interaction with cross-departmental teams.

Excellent interpersonal and communication skills, meticulous eye for detail.

Self-motivation.

Computer literate.

Strong time management awareness and the ability to drive projects forward.

PHYSICAL POSITION REQUIREMENTS

Role will be based on site at Zoetis Tullamore site.

Physical conditions: lifting light weights (e.g. batch paperwork folders), sitting, standing, walking.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.