Short Description:
This position reports to the Senior Manager, GLP Compliance and is responsible to implement, maintain and manage the GLP and non-GLP document archives in compliance with applicable regulatory requirements and Company SOPs.
Responsibilities:
• Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements
• Archive completed GLP and non-GLP study raw data, protocol, reports, electronic data/records, and any other relevant documents following the appropriate cataloging system based on current SOPs
• Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during a FDA inspection
• Ensure that storage conditions are maintained to prevent deterioration of documents or samples for the duration of their retention
• As required, collaborate and coordinate with study director or delegate for the transfer of study data, documents and/or samples to off-site archival locations
• Ensure that only authorized personnel have access to the archive in accordance with governing SOP GLP regulations
• Ensure materials retained in the archive are appropriately indexed for expedient retrieval
• Create and manage the inventory of onsite and offsite storage
• Perform data entry of study records into the archive database
• Collaborates directly with respective departments regarding disposition of archived materials
• Assist in identifying and implementing an electronic archival solution. Develop procedures for electronic archival
• Other responsibilities as assigned
Skills and Knowledge:
• Knowledge of GLP regulatory requirements e.g. 21 CFR Part 58, OECD etc.
• Ability to handle changing priorities if needed in a fast-paced environment
• Proficient in computer skills; departmental database (Access), MS Word, Excel, Adobe, database applications
Ability to work on a team or independently & detail oriented
Excellent written and verbal communication skills
Minimum Qualification(s):
Bachelor's degree or equivalent with 2-3 years of experience in pharmaceutical/ biotechnology industry. Experience in GLP/non-GLP archiving activities.
Experience with electronic archival systems is preferred.
Up to 10% travel time, if required
This position reports to the Senior Manager, GLP Compliance and is responsible to implement, maintain and manage the GLP and non-GLP document archives in compliance with applicable regulatory requirements and Company SOPs.
Responsibilities:
• Revise and develop archive SOPs (and forms) to ensure archival activities comply with regulatory requirements
• Archive completed GLP and non-GLP study raw data, protocol, reports, electronic data/records, and any other relevant documents following the appropriate cataloging system based on current SOPs
• Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during a FDA inspection
• Ensure that storage conditions are maintained to prevent deterioration of documents or samples for the duration of their retention
• As required, collaborate and coordinate with study director or delegate for the transfer of study data, documents and/or samples to off-site archival locations
• Ensure that only authorized personnel have access to the archive in accordance with governing SOP GLP regulations
• Ensure materials retained in the archive are appropriately indexed for expedient retrieval
• Create and manage the inventory of onsite and offsite storage
• Perform data entry of study records into the archive database
• Collaborates directly with respective departments regarding disposition of archived materials
• Assist in identifying and implementing an electronic archival solution. Develop procedures for electronic archival
• Other responsibilities as assigned
Skills and Knowledge:
• Knowledge of GLP regulatory requirements e.g. 21 CFR Part 58, OECD etc.
• Ability to handle changing priorities if needed in a fast-paced environment
• Proficient in computer skills; departmental database (Access), MS Word, Excel, Adobe, database applications
Ability to work on a team or independently & detail oriented
Excellent written and verbal communication skills
Minimum Qualification(s):
Bachelor's degree or equivalent with 2-3 years of experience in pharmaceutical/ biotechnology industry. Experience in GLP/non-GLP archiving activities.
Experience with electronic archival systems is preferred.
Up to 10% travel time, if required
Source: Job Diva – Job Listing