QA Operations Associate - Aseptic

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

Dechra Pharmaceuticals are looking for a QA Associate - Aseptic, to maintain quality policies, procedures and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

You will be working in a Cephalosporin containment facility with cleanroom environment requiring additional PPE gowning and sensitivity health screening. You will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

• Compile and verify all batch related documents are complete.

• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues. Elevate any issues affecting lot manufacturing or release to Management in a timely manner.

• Ensure that any deviations in executed Manufacturing Production Records are appropriately identified.

• Ensure that manufacturing Deviation, Change Management, and other records supporting lot release are reviewed.

• Gather metrics related to lot release, quarterly business reviews, complaints and annual product reviews.

• May develop training programs related to Batch Record Review and Release processes.

• Participate in revision of Batch Record Review and Release SOPs/forms.

• Participate in audits of Aseptic processing.

• Perform Quality Oversight function during media fill and manufacturing of aseptic drugs.

• Perform line clearance and inspection of in-process and finished product.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

• Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates good verbal, written, and interpersonal communication skills are required.

• Demonstrates working knowledge in Microsoft Office applications

• Demonstrate strong attention to detail.

• Ability to work independently with some guidance.

• Excellent verbal and written communication skills.

• Bachelor's Degree in scientific field.

• 3 to 5 years pharmaceutical manufacturing experience.

• Working knowledge of cGMP, quality systems and regulatory requirements (21 CRF Part 11/210/211) practices/principles

• Microbiology experience or understanding is desirable

• Knowledge of validation approaches for processing equipment and clean rooms would be beneficial but not a requirement.

• 3 to 5 years aseptic manufacturing and filling experience in a quality function is preferable but not essential.

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and competitive salary packages for financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.

Dechra Pharmaceuticals PLC

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