Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £25000 - £28000
Job Status: Permanent / Full Time
Job Title: Quality Assurance and Regulatory Affairs Executive
Location: London, NW
Salary: £25k+ (Depending on experience)
Start date: ASAP
Reporting to: RP, QA/RA Manager and Senior Management
Purpose of the Role
Responsible for conducting various tasks required to manage and maintain the Quality Management System and Quality Assurance processes required to deliver Company compliance with the Medicines & Healthcare products Regulatory Agency (MHRA) and Home Office regulatory requirements.
Assist the Quality Assurance & Regulatory Affairs Manager / Responsible Person with day to day requests and Quality & Regulatory functions, required to maintain the QMS and the Business’s compliance to GDP requirements.
- Complete supplier / customer qualification and requalification processes prior to Responsible Person’s final approval.
- Conduct product Complaints and Recall activities as specified in Standard Operating Procedures and / or as directed by the Quality Assurance & Regulatory Affairs Manager / Responsible Person.
- Complete Controlled Drug import / export requests with the Home Office and endorse after shipping.
- Conduct Deviation and CAPA activities as specified in Standard Operating Procedures and / or as directed by the Quality Assurance & Regulatory Affairs Manager / Responsible Person.
- Conduct staff Quality & Regulatory training as delegated by the Quality Assurance & Regulatory Affairs Manager / Responsible Person.
- Assist in the origination, maintenance, updating and management of Standard Operating Procedures within the QMS.
- Liaise with and support staff to address issues and queries with Quality & Regulatory / QMS related matters.
- Check applications / license documentation for new product lines (National, EMA and CE mark).
- Effectively complete and maintain documentation and record keeping activities in the with QMS requirements.
- Conduct Risk Assessment and Change management activities as specified in Standard Operating Procedures and / or as directed by the Quality Assurance & Regulatory Affairs Manager / Responsible Person.
Related Knowledge, Skills, Behaviours, Qualifications and Experience Required
Experience, Knowledge and Understanding
- Experience of working in Quality Assurance / Regulatory compliance role.
- Experience of working in pharmaceutical GDP / GMP compliant business.
- Experience of working with MS office packages (e.g. Word, Excel, PowerPoint, Outlook, Publisher).
- Experience of using Exchequer or other ERP and WMS systems.
Competencies; Skills, Abilities, Behaviours and Work-Related Personal Qualities
Customer Services and Quality
- Being responsive to the priorities and demands of the business to ensure excellent customer service both internally and externally.
- Can do attitude, willing and able to take on new and ongoing challenges.
- Capable of forming positive relationships internally and externally.
- Strives to continuously improve quality of service provided.
Adaptability and Resilience
- Adapts positively to change.
- Ability to reflect and learn from mistakes and make the changes required to improve.
- Able to effectively deal with conflict and deliver positive outcomes.
- Effectively handles the pressures of meeting targets and deadlines.
- Self-starter and proactive, ability to work with little or no supervision
- Excellent interpersonal, team management and decision-making skills
- Strong analytical and organisational skills
- Ability to influence at all levels and problem-solving “can-do “attitude
- Multi-tasking ability; flexible to handle numerous tasks and External / Internal teams
- Deadline driven with keen eye for detail
If this is of interest, please click apply now or speak with Harvey in the Life Sciences team.