Job Introduction
We are looking for:
A QA Officer to be responsible for designing, implementing, and monitoring the QA systems for validation, GMP manufacturing, supplier management, quality control, batch review and release.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Requirements:
- Degree or equivalent in relevant discipline
- Evidence of a high level of proficiency with IT Systems
- Experience in Pharmaceutical Quality systems
- Demonstrable ability to follow written procedures and to evaluate systems and records
- Ability to work to written systems, and a methodical approach to performing duties
- Effective organizational and time management skills
- Excellent attention to detail and a methodical approach
- Appreciation of need to comply with regulatory requirements
- Excellent communication and interpersonal skills, with the ability to provide support to other teams in meeting the commitment to cGMP and patient safety.
Key roles and responsibilities:
- Apply the quality systems in conformance with Quality Policies to ensure compliance with cGMP in line with all licensed activities.
- Assess own workload and training, and discuss with the Senior Quality Manager, R&D any perceived discrepancy between work assigned and ability to complete it.
- Batch Review and Release facilitation
- Ensure that all data relating to a batch intended for release (including data for raw materials, equipment/consumables preparation, manufacturing records, QC records, non-conformances/deviations) are collated, reviewed by the Production, QC and QA managers and provided to the QP responsible for release of the manufactured material.
- Participate in the change control procedure to ensure that all changes affecting the GMP areas are controlled to maintain compliance at all times.
- Participate in the evaluation of trends in non-conformances, environmental monitoring data, critical equipment performance and alert the Senior Quality Manager, R&D to any need for re assessment of quality standards.
- Communicate to the Senior Quality Manager, R&D in an effective manner the compliance status and significant issues. Prepare reports as required detailing key quality performance indicators.
- Participate in audit plans and resource requirements, and internal and supplier audit programmes.
- Prepare audit reports and progress and corrective actions with auditees. Report progress and problems to the Senior Quality Manager, R&D.
- Support QC activities to ensure that samples and documentation are supplied for testing, reporting and review for incorporation into batch documentation and release procedures.
- Act as QA representative on project teams, ensuring projects are managed in conformance to Quality Policies and procedures.
Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.
We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully Integrated
Gene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisation
The Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and due to constant growth we are now recruiting a QA Officer.
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits
- We offer state of the art working environment in our modern Liverpool site
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes
We do more than manufacture batches, we develop medicines!
Why Should You Apply?
- This is an opportunity for you as a QA Officer professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
- Build and shape your career in an environment that sets and commits to the highest standards.
- To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.