QA Document Controller
5 months ago
Job Introduction **We are looking for**:A QA Document Controller to ensure the integrity of documentation, document control and systems to maintain GMP standards**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**:
- GCSE levels or equivalent in Maths and English
- Experience in a GMP document control system role
- MS Word skills and good knowledge of IT systems
- Effective organizational and time management skills
- Excellent attention to detail and a methodical approach. Works to high level of accuracy
- Customer service focused
- Ability to work autonomously
- Able to work well under pressure and organise priorities to meet deadlines
- Maintain confidentiality
- Approachable
- Reliable
**Key roles and responsibilities**:
- Provide document creation support
- Ensure formatting complies.
- Generation and management of document control procedures and templates
- Creation and generation of documentation.
- Control and issue of document and logbook numbers
- Logbook reviews
- Maintain secure and readily retrievable master document files
- Archive management.
- Provide support during regulatory inspections.
- Maintain and manage One Vault electronic document management system
- Admin support on One Vault
- Provide training and coaching to site
- Raise QMS as required to support the document control system
- Provide KPIs for management review.
- Support site activities to provide documents in a timely manner
**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 IntegratedGene 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 characterisationThe Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and** **due to constant growth we are now recruiting a QA Document Controller.
- 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 **Document Controller **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._rnal)
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