- Follows, adheres and enforces GLP, GMP, GDP, USP, ICH guidelines, MedPharm procedures and Policies.
- Adheres to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
- Review of GLP quality related documents, including but not limited to study protocols and amendments, study reports, deviations, validation reports and other relevant documents as needed.
- Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation) for GMP and GLP activities.
- Performs facility and system audits as defined by procedures and Quality Plans and generate reports to document findings.
- Participates in cross functional teams to identify and resolve quality issues as they present themselves, exercise judgement within defined policies, procedures and practices to determine appropriate action (s).
- Identify documentation issues and ensure notification is made to the appropriate personnel.
- Participates, generates and / or review investigations, root cause analysis, Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and laboratory results
- Coordinate with other departments as required to resolve issues and compliance concerns detected during GXP documentation review.
- Participates in the generation and review of trending reports (i.e. process trending, environmental trends, water quality trends, Complaint trending etc.).
- Writes and / or contributes to the creation or revision of Standard Operating Procedures, policies and quality related documents applicable.
- Escalates any quality issues immediately to Quality Assurance management
- Maintain knowledge of current regulatory requirements pertaining to pharmaceutical manufacture.
- Maintain effective communication and partnership with all departments across the organization
- Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations.
- Provides support for regulatory inspections and client audits.
- Serves as an Archivist or Back-up archivist and performs document-controlled activities as needed.
- To perform any other tasks at the request of MedPharm senior management appropriate to the job function.
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