Qc Chemistry Data Reviewer

Job Introduction

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

Dechra are 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.

Main Responsibilities

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

• Review test record, raw data, and documents according to company procedures, data integrity and adherence to specifications.
• Work closely with staff on OOS, OOT, deviation, abort/Invalid, quality event and/or CAPA investigations, reports, and root cause analysis for all testing.
• Write and/or revise and/or review Standard Operating Procedures (SOPs) and protocols.
• Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data.
• Ensure procedures and policies are accurately followed by QC analysts.
• Ensure Good Documentation Practices (GDP) are followed with ALCOA+ principles
• Understand and adhere to the Quality System requirements.
• Strong technical knowledge of various analytical equipment, techniques, and methodology.
• Ensure QC analysts follow cGMPs.
• Strong prioritization, organizational skills and detailed oriented. Coordinate and discuss with other team members for continuous improvement of the data review process. Discussions and provide suggestions to QC analysts for continuous improvement within cGMP requirements and applicable written SOPs, test procedures and methods.
• Apply extensive technical expertise and knowledge of related disciplines/processes.
• Strong prioritization, organizational skills and detailed oriented. Coordinate and discuss with other team members for continuous improvement of the data review process.
• Completion of work within the assigned time frame.
• Maintain a safe and clean laboratory environment.

The Ideal Candidate

Here at Med-Pharmex 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:

• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills
• Minimum Education: Bachelor’s degree or higher in scientific discipline required
• Communicate with others clearly and concisely, ability to work in a fast-paced environment
• Ability to effectively train others on programs and procedures
• Knowledge of Quality Management Systems and LIMS systems
• Experience working with cross-functional teams
• Minimum of 5+ years relevant work experience in Quality Assurance/Data review of Quality Control laboratory in a pharmaceutical industry
• Experience in commercial products is preferred
• Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
• Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills

About The Company

For over 35 years, we’ve committed to serving the animal health community by providing products to extend the health span of companion animals and ensure a safe and abundant food supply. We believe every animal deserves proper care, that’s why we aim to create accessible and results-driven, quality products.