Product Release & Compliance QA Specialist

POSITION SUMMARY

The Product Release & Compliance Quality Assurance (QA) Specialist will play an active role in support
of the general site quality system, with a main focus on batch review and product compliance.
The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA
process and Standard Operating Procedures (SOPs) across all disciplines.
Key oversight responsibilities include, but are not limited to:
• Review of manufacturing batch records
• On-floor oversight and observations of manufacturing activities
• Support in identifying and resolving manufacturing-related issues

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.
• Complete data review at source to ensure data integrity, accuracy, and compliance with regulatory standards
• Preparing batch related documentation for batch release.
• Partake in QA documentation management, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.
• Support change management and corrective/ preventative action (CAPA) systems as required.
• Support ongoing review of events such as: laboratory investigations & environmental excursions and deviations.
• Complete manufacturing observations to ensure that all manufacturing activities comply with Good Manufacturing Practices (GMP) and site procedures.
• Provide QA support to Quality Control including review of Quality Control (QC) raw data.
• Support documentation updates.
• Review of temperature monitoring data of drug substance shipment.
• Support issuance and archival of batch related documentation.
• Support the ongoing site training system and deliver training modules where required.
• Partake in the vendor management process to include vendor assessments, auditing and qualification and supplier change notification. Support site Material requirement specifications.
• Partake in Internal and External audit program.
• Participate in ongoing site 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, Warehouse, GMT, Production and Engineering primarily.

EDUCATION AND EXPERIENCE

Third level Degree in a life science discipline.
At least 2 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.

Full time

Legal statement as below

This job advert indicates the general nature and level of work expected.  It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.  Incumbent may be asked to perform other duties as required.  Additional position specific requirements/responsibilities are contained in approved training curricula. 

Visa status re must be eligible to work and live in Ireland as below

Colleague must be legally eligible to live and work in Ireland.

Summary of our Benefits

In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays,  a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision.