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Sr. Quality Assurance Associate

2 weeks ago

London, United Kingdom WEP Clinical Full time

Do you want to be a part of a team that gives hope to patients living with rare and life-threatening diseases? WEP Clinical partners with physicians, hospitals, drug companies and industry to provide early access to the medicines patients need when they need them the most. Join our team and help transform patient lives

Essential Job Duties and Responsibilities.
- Responsible for ensuring that a compliant quality system is maintained.
- Responsible for ensuring GMP and GDP compliance and best practices within all such regulated activities.
- Responsible for ensuring that operations do not compromise patient safety and the quality of supplied medicines.
- Assist in maintaining a strong Quality culture throughout the UK and EU.
- Provide day-to-day support for business-wide quality enquiries.
- Support the Quality staff to ensure GxP Training is up to date and assist with SOP training.
- Assist in the creation, maintenance and archiving of GxP documentation.
- Contribute to deviation investigations and follow up on CAPAs to ensure timely close-out of actions.
- Log Complaints and support timely investigation and record resolution.
- Contribute to the self-inspection schedule as a supporting auditor.
- Undertake customer, supplier and vendor approvals, including periodic requalification.
- Prioritise emergency orders

Knowledge, Skills and Abilities
- Knowledge of GMP and GDP and MHRA Guidance Note 14
- Practical experience in GxP Supply Chain, Production and Quality Assurance
- Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy
- Degree in Quality Management, life sciences or a related field (desirable)
- Excellent communication skills: verbal and written
- Ability to communicate effectively at all levels of the business
- IT literate: Microsoft Outlook, Word, Excel
- Highly self-motivated with strong interpersonal skills
- Effective planning and time management, organisational and administrative skills

Preferable
- Knowledge of warehousing and logistics processes in a GDP environment
- WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment._
- WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law._