Maintenance of record life cycle management within the document control archive in a compliant and secure manner per cGMP regulatory requirements and in accordance with the Company Quality Manual.
Maintain and follow CGTDM procedures for issuance, receipt, reconciliation, filing, and archives on-site and/or off-site.
Issue document numbers/templates, reconcile, file, and archive technical protocols/reports, validation protocols/reports. Provide execution copies as needed
Enter/maintain information accurately following GDocP to support operations and overall life cycle of documents and records.
Taking inventory and ordering of supplies for the Documentation and Issuance team
Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, etc.) preferred.
Experience in Quality Assurance, CAPA, Change Control, Document Control, and Training Systems.
Continuous improvement mindset.
Ability to communicate clearly (written and verbal) and in an engaging manner with colleagues of various levels of experience and management.
Comfortable working in a team environment and communicating with site and possible other global positions.
Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.
Source: Job Diva – Job Listing