- Bachelor's degree in scientific/life-sciences or related field.
- Experience in managing GMP operations related to small molecule products.
- Experience with CMO relationship/Quality System management.
- Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry.
- Extensive experience of manufacture and test of small molecule drug substance and drug product.
- Experience with an EDMS, Training and Quality Management System.
- Strong detail orientation and focus on quality work product.
- Ability to manage and prioritize projects under tight deadlines.
- Strong written, oral communication, interpersonal, and organization skills.
- Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.
- Ability to travel 15-20% or more as needed.The Senior Quality Specialist will:
- Ensure QA project management and oversight for managing small molecule products.
- Implement, perform, and maintain Quality Systems and procedures.
- Support implementation and promote use of Quality Management Systems and Global Policies.
- Act as a Key User of internal eDMS / eQMS and provide advice and/or training when needed.
- Assess CMO's Quality risk levels and ensure mitigation of risks.
- Lead the development of QTA (Quality Technical Agreement) templates and ensure establishment and maintenance of QTAs with concerned CMOs.
- Perform QA duties and ensure QA oversight during management of supplier quality events.
- Perform internal and external cGMP audits.
- Responsible for suppliers GMP oversight.
- Drive the resolution of major Quality issues.
- Review and approve internal and external deviations, OOS, OOT and related investigations.
- Perform QA role during management of internal Quality Events records in Veeva.
- Quality review of stability data for clinical stage products.
- Approve supplier GMP documents including, but not limited to master batch records, specifications, test procedures.
- Review Regulatory documentation, such as NDAs, INDs and IMPD.
- Collect, report and maintain Quality Management System metrics associated with assigned responsibilities.
- Ensure inspection readiness at assigned CMOs for product related inspections.
- Cooperate with the IMSC Supply Chain, RA-CMC, Analytical and Manufacturing Development in matters relating to assigned clinical Products. If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) or
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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Senior Quality Specialist - Wilmington, United States - Proclinical Staffing
Description
Senior Quality Specialist - Wilmington, DE - Contract
Proclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing. This is a contract position located in Wilmington, DE.
Primary Responsibilities:
The successful candidate will ensure the appropriate use and improvements of Quality Management Systems for small molecule products during clinical development, validation activities, and the manufacturing of the first commercial lot.
Skills & Requirements:
