Denmark Job Openings
ProductLife Group
Student Regulatory Affairs Assistant
Copenhagen
August 4, 2024
Product Life Group are looking for a skilled and enthusiastic student living in Denmark, who can work approximately fifteen (15) hours per week from the client’s offices in Valby. The activities to be provided by students will be varied. Full training will be given. The activities may include the tasks outlined below:
Responsabilities
RA archive management in the headquarter in Valby in line with compliance (GXP, internal SOPs and company Policies)
Receiving incoming documents, indexing those and electronic registering/archiving, physical filing of paper docs
On request (in case of inspections or audits), locate archived documents and provide those to the requesting department
Once those are returned, index and archive them again
Clean documents in line with the documentation retention limits
Special projects in case the company sells products, all relevant RA docs need to be sent to buyer and removed from archive
And vice versa, if the company buys product, archive the incoming docs
Order boxes, binders, stickers, labels, pallets etc. needed for delivering to archiving tasks
Managing incoming post
Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
Assist in the management of Product Life Quality Management System
To participate in training as required for Product Life staff
To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
Profile
Currently studying for a bachelor or master’s degree related with Pharmacy, Pharmaceutical Design, Biology, Chemistry, etc.
Excellent organizational and interpersonal skills
Ability to work well within a team
Process orientated with good attention to detail
Effective oral and written communication skills
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, e DMS, MS Word, MS Excel
Good English language and grammar skills (written fluency a must, verbal fluency preferred), at least one Nordic language mastered is a plus
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