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Quality Assurance Lead
3 months ago
This is a full-time position based on-site for an experienced QA Specialist/Lead. We are seeking a professional with a proactive attitude to offer subject matter expert support to our quality function. Reporting to the Quality Manager, you will bring the enthusiasm necessary to ensure the organization's products meet all quality standards.
Job Summary:
- Lead a team responsible for all aspects of the quality function, ensuring compliance with relevant standards.
- Drive continuous quality improvement to guarantee our products meet all requirements before reaching the client.
- Take charge of various Good Manufacturing and Distribution activities, delivering quality reports and products as per documented procedures, regulations, and guidance.
- Act as a key point of contact for managing Quality Assurance provision.
As the Quality Specialist/Lead, you will:
- Provide Leadership, support, and guidance on all Quality matters.
- Manage the site's Quality Management System, overseeing the progress of site-related deviations, change controls, risk assessments, and CAPAs.
- Ensure operational compliance with relevant standards, including validation activities when necessary.
- Ensure products align with established quality standards and industry benchmarks.
- Effectively handle complaints and manage relationships with external parties.
- Supervise all external and internal audits, including competent authority inspections.
- Be accountable for site training and adherence to Health and Safety regulations.
- Uphold the company's core values to achieve objectives.
- Any other relevant duties as required.
- Possible client travel may be necessary.
Requirements:
- 5-10 years' experience in a Quality Assurance role in pharmaceutical manufacturing, preferably with creams and liquids dosage forms.
- Familiarity with Human Medicines Regulations, Good Manufacturing Practice, Good Distribution Practice, ISO 9001, and ISO 13485.
- Team and Management Leadership skills.
- Experience in overseeing day-to-day Quality activities.
Preferred Skills:
- Degree-level qualification in a relevant subject, preferably in pharmaceutical science.
- Understanding of medicinal drug products/medical device supply chains and external relationships.
- Experience in delivering training and Project Management.
- Strong organizational skills and the ability to lead by example according to the company's core values.
If you believe you are the ideal candidate for this position, please apply with an updated CV attached.
