Training & Documentation Specialist
- Experience Level
- Experienced (non-manager)
Hobson Prior are looking for a Training & Documentation Specialist for an exciting position at a clinical-stage biopharma organisation who are focused on discovering, developing and commercializing innovative pharmaceutical therapies to treat ocular surface diseases.
Please note that to be considered for this role you must have the right to work in this location.
- You will be accountable for coordinating training for employees and ensuring procedures and policies are written, reviewed and approved per compliance requirements and regulations.
- Assists in developing and implementing SOPs to ensure oversight of GXP activities (clinical, manufacturing, laboratory, supply chain, documentation).
- Trackwise SME and supporting QMS development.
- Assists in developing organization of all controlled and uncontrolled GMP Documentation/Records.
- Tracks and maintains training and documentation metric files and trends as well as compliance issues and their resolution on a periodic basis.
- You will work closely with internal departments and service providers to identify, evaluate, and recommend solutions to issues identified.
- Ensures compliance with all internal policies and procedures including safety rules and regulations.
- Assists in planning, preparation of internal and external GXP audits of activities to assess compliance with FDA, ICH GCP, and local regulations, as well as with company SOPs and processes.
- Conducts routine QC reviews of documentation including, but not limited to, batch records, CMO deviations/ OOS investigations, protocols, complaints etc. and manages the closeout of all corrections and corrective and preventative actions.
- Excellent written and oral communication and presentation skills.
- Ability to prioritize and multi-task successfully in a fast-paced environment.
- Strong organizational skills and attention to detail are essential.
- Bachelor's degree in life sciences or related field is required.
- At least 2-4 years' experience in QA or regulated manufacturing environment.
- Must be proficient in MS Office Suite, Trackwise or similar systems
- Prior hands-on experience with electronic data capture systems preferred.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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