Oversee site training covering cGMP requirements, compliance, and corporate policies.
Area Of Responsibility:
- Oversee GxP training, maintain annual training calendar, work with managers to assess training needs, develop curriculum for training requirements,
- Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc.
- Maintain records, ensure conformance to procedures and cGMP, assist in monitoring documentation for period review
- Prepare metrics to discuss at Quality Review Board meetings
- Review Quality records to ensure conformance to approved procedures and cGMP
- Creates and manages documentation requests in electronic systems such as EDMS, Master Control, and Trackwise. in a timely manner to meet established deadlines
- 4+ years of related experience in a pharmaceutical/ drug or medical device industry
- Working knowledge of cGMPs and ISO Standards preferred
- Experience with administration of Learning Management Systems (LMS), Electronic Data Management System (EDMS) and Master Control required
- Experience in Manufacturing and Quality positions, preferably both
- Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
- Public speaking, instructional presentation skills and/ or instructor-led training experience required
- Must have a strong understanding of FDA and other cGMP regulatory requirements as they relate to industrial and non-industrial tasks at a biotech manufacturing facility and/or R&D facility