ProClinical's client, a pharmaceutical manufacturing business, is seeking a QA Documentation Specialist to be based in London on a 3 month contract, with the possibility of extension. The Quality Assurance Documentation Specialist will be responsible for assisting in the implementation and maintenance of the Quality Management System (QMS) by coordinating the revision, review, and approval of SOPs and other GMP documents ensuring compliance with applicable domestic standards and regulations. The scope of activities includes, but is not limited to, document control function, including document login, tracking, processing, distributing, and archiving; management of CAPA, change management, and non-conformance records; maintaining and facilitating the training program, stability studies and QS metrics; and participating in internal audits and supporting external audits.
- Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving in compliance to internal and external requirements (21 CFR 820, ISO 13485, 21CRF211, etc.).
- Coordinates the revision, review, and approval of SOPs and other GMP documents.
- Selects, evaluates, and implements electronic document processing and archiving systems.
- Maintains and facilitates training programs including training matrix, training files, and annual audit of training files.
- Reviews quality outputs, change control, validation and qualification documents.
- Maintains change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols/reports, and other GMP documents.
- Assists in Quality Investigations.
- Generates Incident Reports, Change Controls and CAPA reports, including reviewing adequacy of root cause, corrections, corrective actions, preventative actions and effectiveness.
- Updates and maintains Quality Assurance Operations logs and databases and generating metrics as needed.
- Participates in internal audits and supporting external audits.
Skills and Requirements:
- BS Degree in scientific discipline.
- Quality professional with 2-5 years of hands-on experience with document control process in biopharmaceutical industry.
- Experience with electronic document management system is a plus.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Good computer skills with working knowledge of MS office, such as Word and Excel, Access and Adobe Acrobat professional.
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines.
- Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
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 Nick Dietz on +44 203 3193 033 or upload your CV 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.