Sr. Quality Specialist
Proclinical is currently recruiting for a Senior Quality Specialist for a pharmaceutical company located in Norristown, PA. Successful candidate will be responsible for supporting the Associate Director, Quality with the management of Quality System and Quality Assurance functions.
- Author, review and approve Quality Management System documentation including: Deviation, CAPA, Customer Complaint, Change Control
- Provide GMP, GDP and SOP training to employees
- Perform Self-Inspections
- Perform vendor qualification activities including review of audit questionnaires, performance of on-site audits
- Author, review and approve Quality Agreements with Customers and Vendors
- Participate in and/or host Customer Audits and Regulatory Inspections
- Author, review and approve SOPs, Forms, and Specifications
- Perform pre- and post- execution review and of secondary packaging and labeling batch records
- Perform pre- and post- execution review of facility qualification documents
- Participate in ERP implementation as QA Subject Matter Expert and serve as superuser post go-live
- Report quality metrics to management
- Participate in and/or lead Quality Management Reviews
- Participate in and/or lead Risk Assessment and Mitigation activities
- Liaise with all global QA Departments to harmonize processes
- Lead and implement process improvement projects
- Provide quality and regulatory support to other departments
- Other activities as required
- Bachelor's degree or equivalent experience. 5+ years of experience in pharmaceutical quality assurance.
- Solid understanding of GMP, GDP and other applicable regulatory requirements and the ability to apply them to business scenarios
- Skilled in MS Office (Outlook, Word, Excel, PowerPoint)
- Ability to manage multiple responsibilities simultaneously and adapt to changing priorities
- Results oriented, confident, self-motivated and driven with high energy
- Good analytical abilities and problem-solving techniques
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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