Job description
ORGANISATION
Clinigen Limited is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.
We are currently 1,100 people, headquartered in the UK, with sites in Burton-on-Trent and Weybridge, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and South East Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth. To sustain our growth, we’re on the lookout for motivated, ambitious and committed individuals to join our highly successful global team.
ROLE
This position ensures compliance with the Quality System requirements, works collaboratively with personnel from all other departments, and provides support for continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and company requirements.
- Create, review and maintain quality system SOPs, records and other documents to define and approve quality system functions as assigned
- Assists the Quality Systems Manager with client and regulatory audits and inspections, including audit responses and tracking
- Maintains the audit schedule and audit files
- Initiates and executes internal audits and supplier audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent corrective action status
- Ensures all CAPAs are entered into the quality system, assigned to the appropriate personnel, and completed according to CAPA procedures and within specified time periods
- Works with Subject Matter Experts to ensure CAPA content is accurate, well-documented, meets the requirement of the process, and is completed in a timely manner
- Works with other departments regarding documentation requirements and complex investigations
- Reviews Change Controls, schedules meetings, and tracks completion
- Assists the Quality Systems Manager with tracking and trending Quality System data
- To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
- Perform other related job duties or responsibilities as assigned
REQUIREMENTS
- Bachelor’s Degree required
- 2-3 years of experience in the biopharmaceutical industry, extensive knowledge of FDA GxP regulations
- Experience with various quality systems software
- Maintain a high regard for confidentiality while working with all Clients and proprietary information
- Excellent verbal and written communication skills, with the ability to shape, frame, and present to others
- Ability to work with minimal supervision, set priorities, meet timelines, and manage assigned projects
- Excels in driving projects forward with acceptance by stakeholders for alignment on quality initiatives
- Ability to read and interpret documents, such as SOPs and policies
- Ability to think critically and be innovative to incorporate process improvements
- Excellent oral, written and interpersonal communication skills with active listening ability
- Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast-paced environment
- Must possess a detailed proactive approach in problem solving of daily operations and tasks
- Must demonstrate a high level of initiative and the ability to work well independently and as a team member
- Confidentiality of all clients’ proprietary and pharmaceutical related information
- Highly computer literate; experience operating with all Microsoft Office software
- Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines)
BENEFITS
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